Multivitamin (Adult)

Update of doi: 10.1002/14651858.CD015464. RATIONALE: Higher blood pressure is strongly related to an increased risk of cardiovascular disease. There has been interest in riboflavin (vitamin B2) as a potential intervention to lower blood pressure, particularly for those with a common genetic polymorphism in the methylene tetrahydrofolate reductase enzyme (MTHFR). OBJECTIVES: To assess the benefits and harms of riboflavin supplements compared to placebo or no additional treatment for lowering systolic and diastolic blood pressure. SEARCH METHODS: We searched the Cochrane Hypertension Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase, Clarivate Web of Science, Clarivate Food Science & Technology Abstracts and two clinical trials registries. There were no restrictions on language, publication year, or publication status. The latest search date was 24 October 2024. We also handsearched the reference lists of included studies. ELIGIBILITY CRITERIA: We included randomised controlled trials (RCTs) conducted in adults that evaluated oral riboflavin supplements compared with an inactive control (e.g. placebo or no additional treatment) and measured at least one of the critical outcomes. We did not include trials that evaluated multivitamins containing riboflavin. Participants in both the intervention and control groups were able to receive standard medical therapy for hypertension prior to and during the trial. OUTCOMES: The critical outcomes were systolic blood pressure and diastolic blood pressure. The important outcomes were antihypertensive medication, adverse events and biomarkers of riboflavin status. RISK OF BIAS: We used the Cochrane RoB 2 tool to assess the risk of bias in included studies for the following outcomes: systolic blood pressure, diastolic blood pressure, antihypertensive medication and adverse events. SYNTHESIS METHODS: We used standard Cochrane methods. For the critical outcomes, which were continuous, we calculated mean differences (MD) and 95% confidence intervals (CIs). We used a fixed-effect meta-analysis to pool data for each outcome where possible. We conducted subgroup analyses, inc

RATIONALE: Falls in care facilities are common events, causing considerable morbidity and mortality for older people. This is an update of a review on interventions in care facilities and hospitals first published in 2010 and updated in 2012 and 2018 on interventions in care facilities and hospitals. This review has now been split into separate reviews for each setting. OBJECTIVES: To assess the benefits and harms of interventions designed to reduce the incidence of falls in older people in care facilities. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, and two trial registers to 10 May 2024 and used reference checking, citation searching, and contact with authors to identify eligible trials and records. ELIGIBILITY CRITERIA: We included randomised controlled trials (RCTs) of any intervention for preventing falls in older people (aged over 65 years) in care facilities with any comparator. We excluded trials conducted in places of residence that do not provide residential health-related care or rehabilitative services. We excluded trials where falls were recorded as adverse events of the intervention and those recruiting participants post-stroke or living with Parkinson's disease. OUTCOMES: Critical outcomes were rate of falls (number of falls per unit time) and number of fallers (risk of experiencing one or more falls). Important outcomes were risk of fracture, adverse events, and economic outcomes. RISK OF BIAS: We assessed risk of bias in the included studies against nine items (seven items from Cochrane's RoB 1 tool, plus method of ascertaining falls and baseline imbalance). SYNTHESIS METHODS: Two review authors independently performed study selection and data analysis. We calculated rate ratios (RaR) with 95% confidence intervals (CIs) for rate of falls and risk ratios (RRs) with 95% CIs for outcomes of risk of falling (number of people falling) and risk of fracture. We adjusted for clustering if not undertaken by trial authors. We grouped the results of trials with comparable interventions and participant characteristics, and pooled results where appropriate using the generic inverse varian

BACKGROUND: Longer effects of multivitamin-mineral (MVM) supplementation on late-life cognitive function remain untested using in-person, detailed neuropsychological assessments. Furthermore, insufficient evidence exists for healthcare providers to recommend daily MVM supplements to prevent cognitive decline. OBJECTIVES: This study aimed to test MVM effects on cognitive change using in-person, detailed neuropsychological assessments and conduct a meta-analysis within COSMOS (COcoa Supplement and Multivitamin Outcomes Study) cognitive substudies for a robust evaluation of MVM effects on cognition. METHODS: COSMOS is a 2 × 2 factorial trial of cocoa extract (500 mg flavanols/d) and/or a daily MVM supplement for cardiovascular disease and cancer prevention among 21,442 United States adults aged ≥60 y. There were 573 participants in the clinic subcohort of COSMOS (that is, COSMOS-Clinic) who completed all cognitive tests administered at baseline. For the meta-analysis, we included nonoverlapping participants across 3 COSMOS cognitive substudies: COSMOS-Clinic (n = 573); COSMOS-Mind (n = 2158); COSMOS-Web (n = 2472). RESULTS: In COSMOS-Clinic, we observed a modest benefit of MVM compared with placebo on global cognition over 2 y {mean difference [95% confidence interval (CI)] = 0.06 SD units (SU) (-0.003, 0.13)}, with a significantly more favorable change in episodic memory [mean difference (95% CI) = 0.12 SU (0.002, 0.23)] but not in executive function or attention [mean difference (95% CI) = 0.04 SU (-0.04, 0.11)]. The meta-analysis of COSMOS substudies showed clear evidence of MVM benefits on global cognition [mean difference (95% CI) = 0.07 SU (0.03, 0.11); P = 0.0009] and episodic memory [mean difference (95% CI) = 0.06 SU (0.03, 0.10); P = 0.0007]; the magnitude of effect on global cognition was equivalent to reducing cognitive aging by 2 y. CONCLUSIONS: In COSMOS-Clinic, daily MVM supplementation leads to a significantly more favorable 2-y change in episodic memory. The meta-analysis within COSMOS cognitive substudies indicates that daily MVM significantly benefits both global cognition and episodic memory. These findings within the COSMOS trial support the be

PURPOSE: Hip fracture is a severe complication of osteoporosis and is associated with a significant healthcare burden worldwide. This meta-analysis explores the association between combined multivitamin use and hip fracture risk. Our results provide more patient-centered insight into the impact of supplement use on osteoporosis outcomes. METHODS: We searched three online databases in August 2019 and included studies that reported on multivitamin use in patients with osteoporotic hip fractures. The inclusion criteria were (1) adult patients with osteoporotic hip fractures, (2) availability of full-text articles in English, and (3) at least 1 year of follow-up. No suitable randomized controlled trials could be identified for inclusion in the analysis. The quality of the included studies was assessed using the Newcastle-Ottawa Scale (NOS). RESULTS: Eight studies containing 80,148 subjects in total were included in this study. Among these, 4237 cases of fragility hip fracture were reported. The average age was 69±5.3 years, and 21% of subjects were male. Multivitamin use was found to be significantly associated with a lower risk of sustaining a fragility hip fracture (OR 0.49, 95%CI: 0.32-0.77). The Begg and Mazumdar test and funnel plot indicated that no significant publication bias was present. CONCLUSION: Combined multivitamins are amongst the most widely used supplements and are often preferred over single vitamins. Our meta-analysis indicates that multivitamin use is significantly protective against osteoporotic hip fracture. In the future, randomized controlled trials should be performed to establish multivitamins as effective preventative measures for this injury.

BACKGROUND: The role of nutritional supplements and dietary interventions in preventing mortality and cardiovascular disease (CVD) outcomes is unclear. PURPOSE: To examine evidence about the effects of nutritional supplements and dietary interventions on mortality and cardiovascular outcomes in adults. DATA SOURCES: PubMed, CINAHL, and the Cochrane Library from inception until March 2019; ClinicalTrials.gov (10 March 2019); journal Web sites; and reference lists. STUDY SELECTION: English-language, randomized controlled trials (RCTs) and meta-analyses of RCTs that assessed the effects of nutritional supplements or dietary interventions on all-cause mortality or cardiovascular outcomes, such as death, myocardial infarction, stroke, and coronary heart disease. DATA EXTRACTION: Two independent investigators abstracted data, assessed the quality of evidence, and rated the certainty of evidence. DATA SYNTHESIS: Nine systematic reviews and 4 new RCTs were selected that encompassed a total of 277 trials, 24 interventions, and 992 129 participants. A total of 105 meta-analyses were generated. There was moderate-certainty evidence that reduced salt intake decreased the risk for all-cause mortality in normotensive participants (risk ratio [RR], 0.90 [95% CI, 0.85 to 0.95]) and cardiovascular mortality in hypertensive participants (RR, 0.67 [CI, 0.46 to 0.99]). Low-certainty evidence showed that omega-3 long-chain polyunsaturated fatty acid (LC-PUFA) was associated with reduced risk for myocardial infarction (RR, 0.92 [CI, 0.85 to 0.99]) and coronary heart disease (RR, 0.93 [CI, 0.89 to 0.98]). Folic acid was associated with lower risk for stroke (RR, 0.80 [CI, 0.67 to 0.96]; low certainty), whereas calcium plus vitamin D increased the risk for stroke (RR, 1.17 [CI, 1.05 to 1.30]; moderate certainty). Other nutritional supplements, such as vitamin B6, vitamin A, multivitamins, antioxidants, and iron and dietary interventions, such as reduced fat intake, had no significant effect on mortality or cardiovascular disease outcomes (very low- to moderate-certainty evidence). LIMITATIONS: Suboptimal quality and certainty of evidence. CONCLUSION: Reduced salt intake, omega-3 LC-PUF

Previous studies have not drawn a consistent conclusion about effect of multivitamin and multimineral supplementation (MVMS) on blood pressure. A comprehensive search of PubMed, Embase and Cochrane Library (up to May 2018) and references of relevant articles was undertaken. The present meta-analysis included 12 randomized controlled trials (RCTs), of which eight RCTs in 2011 subjects evaluated the effect of MVMS on blood pressure and four RCTs in 21,196 subjects evaluated the effect of MVMS on the risk of hypertension. MVMS had a lowering effect on systolic blood pressure (SBP) and diastolic blood pressure (DBP): the weighted mean difference (WMD) was -1.31 mmHg (95% CI, -2.48 to -0.14 mmHg) and -0.71 mmHg (95% CI, -1.43 to 0.00 mmHg), respectively. Subgroup analysis indicated that the lowering effect of MVMS on blood pressure was only significant in 134 subjects with chronic disease but not in 1580 healthy subjects, and the WMD for systolic blood pressure (SBP) and DBP in subjects with chronic disease was -6.29 mmHg (95% CI, -11.09 to -1.50 mmHg) and -2.32 mmHg (95% CI, -4.50 to -0.13 mmHg), respectively. The effect size of MVMS on SBP in 58 hypertensive subjects (WMD, -7.98 mmHg; 95% CI, -14.95 to -1.02 mmHg) was more than six times of that in 1656 normotensive subjects (WMD, -1.25 mmHg; 95% CI, -2.48 to -0.02 mmHg). However, no significant effect on DBP was observed in both hypertensive and normotensive subgroups. There was no significant effect of MVMS on risk of hypertension in 22,852 subjects with a normal blood pressure at baseline. In conclusion, although MVMS had a significant lowering effect on blood pressure in normotensive subjects, the lowering effect was too small to effectively prevent future hypertension. MVMS may be an effective method for blood pressure control in subjects with chronic disease including hypertension, but the sample size of subjects with hypertension or other chronic disease was too small, and more well-designed RCTs are needed to confirm this result.

BACKGROUND: Multiple studies have attempted to identify the association between multivitamin/mineral (MVM) supplementation and cardiovascular disease (CVD) outcomes, but the benefits remain controversial. We performed a systematic review and meta-analysis of the associations between MVM supplementation and various CVD outcomes, including coronary heart disease (CHD) and stroke. METHODS AND RESULTS: We conducted a comprehensive search of Medline, Embase, and the Cochrane Library for studies published between January 1970 and August 2016. We included clinical trials and prospective cohort studies in the general population evaluating associations between MVM supplementation and CVD outcomes. Data extraction and quality assessment were independently conducted by 2 authors, and a third author resolved discrepancies. Eighteen studies with 2 019 862 participants and 18 363 326 person-years of follow-up were included in the analysis. Five studies specified the dose/type of MVM supplement and the rest did not. Overall, there was no association between MVM supplementation and CVD mortality (relative risk [RR], 1.00; 95% confidence interval [CI], 0.97-1.04), CHD mortality (RR, 1.02; 95% CI, 0.92-1.13), stroke mortality (RR, 0.95; 95% CI, 0.82-1.09), or stroke incidence (RR, 0.98; 95% CI, 0.91-1.05). There was no association between MVM supplements and CVD or CHD mortality in prespecified subgroups categorized by mean follow-up period, mean age, period of MVM use, sex, type of population, exclusion of patients with history of CHD, and adjustment for diet, adjustment for smoking, adjustment for physical activity, and study site. In contrast, MVM use did seem to be associated with a lower risk of CHD incidence (RR, 0.88; 95% CI, 0.79-0.97). However, this association did not remain significant in the pooled subgroup analysis of randomized controlled trials (RR, 0.97; 95% CI, 0.80-1.19). CONCLUSIONS: Our meta-analysis of clinical trials and prospective cohort studies demonstrates that MVM supplementation does not improve cardiovascular outcomes in the general population. © 2018 American Heart Association, Inc.

BACKGROUND: It has been proposed that antioxidants may prevent cellular damage in the retina by reacting with free radicals that are produced in the process of light absorption. Higher dietary levels of antioxidant vitamins and minerals may reduce the risk of progression of age-related macular degeneration (AMD). OBJECTIVES: The objective of this review was to assess the effects of antioxidant vitamin or mineral supplementation on the progression of AMD in people with AMD. SEARCH METHODS: We searched CENTRAL (2017, Issue 2), MEDLINE Ovid (1946 to March 2017), Embase Ovid (1947 to March 2017), AMED (1985 to March 2017), OpenGrey (System for Information on Grey Literature in Europe, the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 29 March 2017. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared antioxidant vitamin or mineral supplementation (alone or in combination) to placebo or no intervention, in people with AMD. DATA COLLECTION AND ANALYSIS: Both review authors independently assessed risk of bias in the included studies and extracted data. One author entered data into RevMan 5; the other author checked the data entry. We graded the certainty of the evidence using GRADE. MAIN RESULTS: We included 19 studies conducted in USA, Europe, China, and Australia. We judged the trials that contributed data to the review to be at low or unclear risk of bias.Nine studies compared multivitamins with placebo (7 studies) or no treatment (2 studies) in people with early and moderate AMD. The duration of supplementation and follow-up ranged from nine months to six years; one trial followed up beyond two years. Most evidence came from the Age-Related Eye Disease Study (AREDS) in the USA. People taking antioxidant vitamins were less likely to progress to late AMD (odds ratio (OR) 0.72, 95% confidence interval (CI) 0.58 to 0.90; 2445 participants; 3 RCTs; moderate-certai

BACKGROUND: Micronutrient deficiencies are common among adults living with HIV disease, particularly in low-income settings where the diet may be low in essential vitamins and minerals. Some micronutrients play critical roles in maintenance of the immune system, and routine supplementation could therefore be beneficial. This is an update of a Cochrane Review previously published in 2010. OBJECTIVES: To assess whether micronutrient supplements are effective and safe in reducing mortality and HIV-related morbidity of HIV-positive adults (excluding pregnant women). SEARCH METHODS: We performed literature searches from January 2010 to 18 November 2016 for new randomized controlled trials (RCTs) of micronutrient supplements since the previous review included all trials identified from searches prior to 2010. We searched the CENTRAL (the Cochrane Library), Embase, and PubMed databases. Also we checked the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and the ClinicalTrials.gov trials registers. We also checked the reference lists of all new included trials. SELECTION CRITERIA: We included RCTs that compared supplements that contained either single, dual, or multiple micronutrients with placebo, no treatment, or other supplements. We excluded studies that were primarily designed to investigate the role of micronutrients for the treatment of HIV-positive participants with metabolic morbidity related to highly active antiretroviral therapy (HAART). Primary outcomes included all-cause mortality, morbidity, and disease progression. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, and appraised trial quality for risk of bias. Where possible, we presented results as risk ratios (RR) for dichotomous variables, as hazard ratios (HRs) for time-to-event data, and as mean differences (MD) for continuous variables, each with 95% confidence intervals (CIs). Since we were often unable to pool the outcome data, we tabulated it for each comparison. We assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: We included 33 trials with 10,325 participants, of which 17 trials were

Use of dietary supplements is rising in countries where colorectal cancer is prevalent. We conducted a systematic literature review and meta-analyses of prospective cohort studies on dietary supplement use and colorectal cancer risk. We identified relevant studies in Medline, Embase and Cochrane up to January 2013. Original and peer-reviewed papers on dietary supplement use and colorectal cancer, colon cancer, or rectal cancer incidence were included. "Use-no use"(U-NU), "highest-lowest"(H-L) and "dose-response"(DR) meta-analyses were performed. Random-effects models were used to estimate summary estimates. In total, 24 papers were included in the meta-analyses. We observed inverse associations for colorectal cancer risk and multivitamin (U-NU: RR = 0.92; 95% CI: 0.87,0.97) and calcium supplements (U-NU: RR = 0.86; 95% CI: 0.79,0.95; H-L: RR = 0.80; 95% CI: 0.70,0.92; DR: for an increase of 100 mg/day, RR = 0.96; 95% CI: 0.94,0.99). Inconsistent associations were found for colon cancer risk and supplemental vitamin A and vitamin C, and for colorectal cancer risk and supplemental vitamin D, vitamin E, garlic and folic acid. Meta-analyses of observational studies suggest a beneficial role for multivitamins and calcium supplements on colorectal cancer risk, while the association with other supplements and colorectal cancer risk is inconsistent. Residual confounding of lifestyle factors might be present. Before recommendations can be made, an extensive assessment of dietary supplement use and a better understanding of underlying mechanisms is needed. © 2014 UICC.

Large-scale randomized trials have found that multivitamin-multimineral (MVM) supplements and cocoa flavanols may benefit several age-related chronic conditions among older adults, but it remains unclear whether these two supplements directly slow the biological aging process. This prespecified ancillary study evaluated the 2-year effect of a daily MVM (Centrum Silver) and cocoa extract (500 mg cocoa flavanols per day, including 80 mg (-)-epicatechin) on five DNA methylation measures of biological aging (PCHannum, PCHorvath, PCPhenoAge, PCGrimAge and DunedinPACE) among 958 participants (482 women and 476 men) in the COcoa Supplement and Multivitamin Outcomes Study (COSMOS). Compared with placebo, daily MVM supplementation modestly reduced the rate of increase of second-generation epigenetic clocks, with a between-group difference in yearly change of -0.113 years (95% confidence interval (CI) -0.205 to -0.020; P = 0.017) for PCGrimAge and -0.214 years (-0.410 to -0.019; P = 0.032) for PCPhenoAge. MVM had a stronger effect on PCGrimAge among those with accelerated biological aging at baseline (-0.236 [-0.380 to -0.091]) compared with those with normal or decelerated biological aging (-0.013 [-0.130 to 0.104]; P = 0.018 for interaction). Cocoa extract did not have an effect on the five epigenetic clocks tested. Although the statistically significant but small effects of daily MVM supplementation on slowing biological aging are encouraging, additional studies are needed to determine the clinical relevance of daily MVM supplementation on epigenetic clocks and whether such effects can help explain the beneficial effects of MVM supplementation on aging-related chronic conditions. © 2026. The Author(s), under exclusive licence to Springer Nature America, Inc.

BACKGROUND: Adequate intake of carotenoids and vitamin E supports healthy aging, yet evidence is limited on whether multivitamin-multimineral (MVM) supplementation changes serum concentrations over time. OBJECTIVE: The aim of this investigation was to evaluate the effect of daily MVM supplementation among older adults on serum carotenoid and vitamin E concentrations over a 2-year period. DESIGN: The COcoa Supplement and Multivitamin Outcomes Study is a large-scale, randomized, placebo-controlled, 2 × 2 factorial trial, designed to test the effects of daily MVM and cocoa extract supplementation for chronic disease prevention. Participants completed semiannual questionnaires and provided optional biospecimen samples at baseline, 1-year, and 2-year follow-up. PARTICIPANTS AND SETTING: Between 2015 and 2020, US adults (women aged 65 years and older, men aged 60 years and older) without major cardiovascular disease or recent cancer were enrolled in the COcoa Supplement and Multivitamin Outcomes Study. This analysis included biospecimen substudy participants with blood samples provided at baseline and ≥1 follow-up timepoint (n = 400; 1 excluded due to unusable sample; final N = 399). INTERVENTION: Participants were randomized to receive daily MVM supplementation or a placebo, with or without cocoa extract. MAIN OUTCOME MEASURES: Changes in serum carotenoids and α-tocopherol concentrations were evaluated over the 2-year follow-up. STATISTICAL ANALYSES: Multivariable linear mixed models estimated changes in serum biomarker concentrations, comparing MVM with placebo, adjusting for covariates (age, sex, and cocoa extract intervention). RESULTS: Increases in serum carotenoids and α-tocopherol levels with MVM supplementation emerged at year 1 and persisted through year 2. MVM supplementation led to significantly higher serum concentrations of total carotenoids (percent change: 15.5%; 95% CI, 8.72 to 22.70), lutein (percent change: 17.17%; 95% CI, 7.53 to 27.66), beta carotene (percent change: 46.96%; 95% CI, 35.10 to 59.85), and α-tocopherol (percent change: 29.50%; 95% CI, 22.88 to 36.47) over 2 years compared with placebo. No significant differences were observed for lyco

BACKGROUND AND OBJECTIVES: Vitamin deficiencies are closely associated with the development of chronic diseases. Therefore, effective and safe intervention strategies are critical to improving vitamin nutritional status. This study aimed to assess the effectiveness and differential impacts of nutrition education and multi-vitamin supplementation, providing a basis for selecting safer intervention strategies. METHODS AND STUDY DESIGN: A 4-week, double-blind, randomized controlled trial was conducted among 155 adults (aged 18-65 years) with confirmed deficiencies in fat-soluble vitamins (A, D, or E). Participants were randomly assigned to receive either nutrition education with a multivitamin supplement or nutrition education with placebo. The concentrations of fat-soluble vitamins (A, D, or E), as well as their deficiency rates, were compared before and after the intervention. RESULTS: A total of 155 participants completed the study. There were no significant differences in demographic characteristics between the two groups. In both groups, the concentration of vitamins (A, D, or E) significantly increased (all p < 0.001), and the deficiency rates for all three vitamins significantly decreased (all p < 0.001). However, there were no significant differences in the concentrations or deficiency rates of vitamins (A, D, or E) between the two groups after intervention (all p > 0.05). CONCLUSIONS: Multivitamin supplements are not superior to nutrition education. Nutrition education alone may be a safer and effective approach to addressing deficiencies in vitamins A, D, and E, while reducing the risks as-sociated with unnecessary vitamin supplementation in the general population.

To assess the feasibility of a randomized controlled trial (RCT) comparing 5-methyltetrahydrofolate (5-MTHF) and folic acid (FA) in couples with recurrent pregnancy loss. Pregnancy loss affects up to 15% of pregnancies, with over half of cases remaining unexplained. Emerging evidence suggests that folate metabolism, particularly in individuals carrying methylenetetrahydrofolate reductase polymorphisms such as C677T and A1298C variants, may influence reproductive outcomes. A double-blind, RCT feasibility trial was conducted in Australia with 22 reproductive dyads randomized to receive either 5-MTHF or FA prenatal multivitamins. Participants adhered to dietary restrictions, abstained from conception for two cycles, and completed regular assessments. Primary outcomes included feasibility, adherence, acceptability, and preliminary efficacy based on biochemical markers and pregnancy outcomes. The trial demonstrated high acceptability (86% in arm A [MTHF-A] and 94% in arm B [FA-B]) and adherence rates for supplement use over 78% in each arm. Unmetabolized FA concentration decreased in the 5-MTHF group but rose significantly in the FA group. A critical finding was the degradation of 5-MTHF in retained samples, highlighting formulation instability as a confounder. A fully online RCT comparing 5-MTHF and FA is feasible. Future trials should address formulation stability and expand sample size to evaluate clinical efficacy and personalized folate strategies.

OBJECTIVE: To explore the effects of multivitamin combined with magnesium sulfate on placental hemodynamics, coagulation function, and maternal and infant outcomes in preeclampsia patients. METHODS: A randomized controlled study was conducted among 194 pregnant women diagnosed with preeclampsia between April 2022 and April 2023. Participants were randomly assigned to either the control group (n = 97), receiving intravenous magnesium sulfate alone, or the observation group (n = 97), receiving magnesium sulfate combined with multivitamin supplementation. Magnesium sulfate was administered with a loading dose of 2.5-5 g via rapid IV infusion and a maintenance dose of 5-20 g by continuous drip. The observation group additionally received one oral multivitamin tablet (Bayer S.A., 30 tablets/box) once daily in the morning. The treatment duration for both groups was two weeks. Blood pressure, 24-hour urinary protein, placental Doppler indices (RI, PI, S/D), coagulation markers (PT, APTT, FIB, TT), and maternal-infant outcomes were measured and compared. RESULTS: After treatment, both groups showed significant reductions in systolic and diastolic blood pressure, but there was no significant difference between them. However, the observation group had significantly lower 24-hour urinary protein levels (0.71 ± 0.31 g vs. 0.92 ± 0.28 g, P < 0.001). Coagulation function improved in both groups, with the observation group showing greater improvements: longer PT, APTT, and TT times, and lower FIB levels (P < 0.01). Placental hemodynamics also improved more in the observation group, with lower resistance indices and S/D ratios in both the umbilical and spiral arteries (P < 0.001). The observation group had better maternal and neonatal outcomes, including fewer cases of postpartum hemorrhage (10 vs. 22, P = 0.020), low birth weight (10 vs. 23, P = 0.013), and NICU admissions (9 vs. 21, P = 0.018). Eclampsia occurred only in the control group (3 cases), though this was not statistically significant (P = 0.081). Other outcomes, such as uterine inertia and neonatal asphyxia, were similar between groups. Subgroup analysis showed that patients with severe preeclampsia in the observat

BACKGROUND: Male infertility is influenced by a variety of etiologies, including quantitative and qualitative impairments in spermatogenesis. Antioxidants scavenge reactive oxygen species (ROS), which reduce sperm motility, cause damage to DNA, and lead to subsequent apoptosis in sperm cells. This trial aimed to evaluate the effect of oral Synbiotic and a multivitamin-mineral supplement for men helping to improve male fertility (SperiGen), as an antioxidant agent, on the spermatogram in idiopathic Oligoasthenoteratozoospermia (iOAT). MATERIALS AND METHODS: This double-blind randomized clinical trial was conducted on infertile males with iOAT. Totally, 73 patients with iOAT were blindly randomized into two groups; one group received SperiGen as an antioxidant agent in addition to placebo. In the next group, in addition to SperiGen, the patients received 500 mg Synbiotic (FamiLact) on a daily basis. They continued their treatments for 3 months. Semen parameters were measured before and after the intervention. RESULTS: Supplementations with a combination of Synbiotic and SperiGen compared with SperiGen and placebo significantly increased the average change of sperm progressive motility (p = 0.001), DNA fragmentation (p = 0.001), and diminished the levels of non-motile sperm (p = 0.018). Eventually, within-group analysis indicated that all parameters were significantly improved in both groups, except for non-progressive motility in the SperiGen and placebo group. CONCLUSION: The combination of Synbiotic and SperiGen (an antioxidant supplement) appears to be much more effective than using an antioxidant alone in improving the DNA fragmentation, concentration, and progressive motility of sperm. TRIAL REGISTRATION: IRCT20190810044500N6, 2020-09-05. https://irct.behdasht.gov.ir/trial/46773. https://trial.medpath.com/clinical-trial/7ad7a7af5cba37f3/evaluating-symbiotic-therapy-male-infertility. © 2026 The Japanese Urological Association.

BACKGROUND: Multivitamin-multimineral (MVM) supplements have been associated with lower blood pressure (BP) in several small trials. We investigated the effects of a MVM on incident hypertension and BP in a secondary analysis of the COcoa Supplement and Multivitamin Outcomes Study (COSMOS). METHODS: COSMOS is a 2×2 factorial, double-blinded RCT testing effects of cocoa extract and MVM supplementation among women aged ≥65 years and men aged ≥60 years. Among 8905 COSMOS participants free from hypertension, effects of MVM supplementation on incident hypertension were investigated. Hypertension diagnosis was ascertained through self-reports. Additionally, in two substudies with BP measurements (N = 529 at clinic by research staff and 994 at home by technician), we evaluated the effects on 2-year BP changes. RESULTS: Incident hypertension was observed in N = 1034 (22.9%) in MVM arm and N = 1039 (23.6%) in placebo arm over a median of 3.4 years (IQR: 3.0, 3.9) of follow-up, with hazard ratio (HR) 0.98 [95% CI: 0.90, 1.06]. Effects differed according to baseline diet quality, with HRs of incident hypertension 0.81 [0.70, 0.95] and 1.14 [1.01, 1.28] among participants with lower and higher Alternate Mediterranean Diet score, respectively (P-interaction = .001). There was no effect of MVM on 2-year changes in systolic BP (4.4 mmHg in MVM; 4.5 mmHg in placebo), while pronounced effects were observed for baseline normal BP (P-interaction = .004). CONCLUSIONS: MVM supplementation versus placebo did not reduce hypertension incidence or lower BP overall. Exploratory analyses showed greater reduction in hypertension risk and BP changes among those with lower dietary quality and normal BP at baseline, respectively. CLINICAL TRIAL REGISTRATION: NCT02422745. © The Author(s) 2025. Published by Oxford University Press on behalf of American Journal of Hypertension, Ltd. All rights reserved. For commercial re-use, please contact [email protected] for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact [email protected]

Objective: The metabolite trimethylamine N-oxide (TMAO) is a biomarker influenced by diet and linked to atherosclerosis, thrombosis, and cardiovascular disease (CVD). Choline is a crucial nutrient involved in maintaining cell structure, promoting liver health, and neurotransmission. However, human evidence is limited whether cocoa extract (CE) changes TMAO and choline levels over time. The COcoa Supplement and Multivitamin Outcomes Study (COSMOS) is a randomized, placebo-controlled, 2 × 2 factorial trial testing a CE supplement (containing 500 mg d-1 flavanols) and a daily multivitamin for chronic disease prevention in 21 442 older adults. We conducted a pilot study of the impact of CE on 1 year changes in TMAO and choline in COSMOS participants to facilitate sample size calculations for larger analyses of this trial in the future. In a pilot intention to treat analyses, linear mixed effect models were used to explore serum TMAO and choline trajectories in relation to CE assignment, adjusting for age, sex, and the other randomization arm. Methods: We randomly selected 40 COSMOS participants with blood samples at baseline and year 1. TMAO and choline were measured in plasma samples by liquid chromatography with stable isotope dilution tandem mass spectrometry. We excluded 3 of 40 participants due to extreme TMAO values ≥32.9 μM. Results: The mean age at baseline was 77 ± (5.5) years, and 18 (48.7%) were female. Randomization successfully distributed baseline demographic, clinical, behavioral, and dietary characteristics by treatment group. Among the 37 COSMOS participants, those assigned to take a CE supplement, as compared to placebo, had similar TMAO and choline levels at baseline but showed trends toward lower levels of TMAO (-0.60 [95% CI, (-3.76, 2.55)]) at 1 year. However, the between-group differences in the 1 year changes in TMAO (CE minus placebo) were not statistically significant (-1.16 [95% CI, (-5.81, 3.50)]; P = 0.62). In contrast, the group assigned CE showed trends toward higher levels of choline (0.84 (-1.57, 3.25)) at year 1, but the between-group differences in the 1 year changes in choline were again not statistically significant (2.23 [95% CI

OBJECTIVE: To examine the long-term effect of cocoa flavanols on inflammaging biomarkers in the COcoa Supplement and Multivitamin Outcomes Study (COSMOS). METHODS: COSMOS is a large, randomised, double-blind, placebo-controlled, 2 × 2 factorial trial testing the effects of a cocoa extract supplement (containing 500 mg cocoa flavanols/day, including 80 mg (-)-epicatechin) among women aged ≥65 years and men aged ≥60 years. This ancillary study measured five widely used serum inflammaging biomarkers, including three pro-inflammatory markers (high-sensitivity C-reactive protein [hsCRP], interleukin-6, tumour necrosis factor-α), one anti-inflammatory cytokine (interleukin-10) and one pleotropic cytokine (interferon-γ [IFN-γ]) in a random sample of 598 participants with biospecimens collected at baseline, Year 1, and Year 2. RESULTS: The mean age was 70.0 ± 5.6 years, and 49.8% were female. Cocoa extract supplementation significantly decreased hsCRP levels compared with placebo, with a between-group difference in yearly percentage change relative to baseline levels of -8.4% (95% CI, -14.1% to -2.3%; nominal P = .008; Holm-adjusted P value = .039). Moreover, cocoa extract increased IFN-γ with a 6.8% (95% CI, 1.5% to 12.2%, nominal P = .011; Holm-adjusted P value = .043) difference in yearly percentage change versus placebo. The effects of cocoa extract on other inflammatory markers were not significant (all adjusted P values >.05). CONCLUSION: Cocoa extract supplementation significantly decreased hsCRP, supporting a role in modulating the chronic inflammaging process as a potential mechanism underlying its cardio-protective effects, including a 27% reduction in cardiovascular disease death in the COSMOS trial. The biological effect of increased IFN-γ by cocoa extract warrants further exploration. © The Author(s) 2025. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For commercial re-use, please contact [email protected] for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further informatio

<p>Introduction: Efficacy and safety of a novel total parenteral nutrition formula for chronic kidney disease patients, OPF-109, containing multivitamins based on the FDA2000 recommendation were investigated. METHODS: We conducted a phase III clinical trial administering OPF-109 (n = 63) or the control solutions (combination of marketed products including multivitamin based on American Medical Association 1975 guidelines) (n = 61) to the chronic kidney disease patients for 8 days. Blood concentrations of proteins and vitamins and safety were evaluated. The primary efficacy endpoint was protein concentration (serum T-P, ALB, pre-ALB, transferrin) on day 8. Safety endpoints were hematological data, blood biochemistry data, vital signs, and adverse events. RESULTS: Values of blood protein until day 8 were similar in 2 groups although those of vitamins B1, B6, C, and folic acid (contained more in OPF-109) were higher in the OPF-109 group. For both groups, vitamin C concentration of day 1 was below the normal range, which restored to within the range in the OPF-109 group but decreased in the control group on day 8. Vitamin K concentration (contained less in OPF-109) was over the normal range on day 1 in both groups and decreased to slightly higher than the normal range in the OPF-109 group while increased to higher than day 1 value in the control group on day 8. Safety was similar in 2 groups. CONCLUSION: Efficacy and safety of OPF-109 and usefulness of multivitamins based on the FDA2000 recommendation formula were confirmed in chronic kidney disease patients. </p>. © 2025 The Author(s). Published by S. Karger AG, Basel.

BACKGROUND: Dietary supplement and complementary and alternative medication (CAM) use can contribute to drug interactions, polypharmacy, nonadherence with prescription medications, and healthcare expenses, whereas evidence supporting benefits of using these products is sparse. There is a lack of current published literature describing the patterns or predictors of their use in community-dwelling older adults. MATERIALS AND METHODS: We performed a cross-sectional analysis of community-dwelling adults from Australia and the US, aged 70 years and older (65 years for US minorities), enrolled in the ASPirin in Reducing Events in the Elderly (ASPREE) study. At study enrollment, eligible participants were required to be without concurrent 5-year life-limiting illness and free of documented evidence of cardiovascular disease, dementia, or significant physical disability. During the final study visit, a questionnaire was administered to collect information about supplement/CAM use. Data from 15,729 participants who completed this questionnaire between January 2017 and January 2018 were analyzed. Descriptive statistics were used to report the prevalence and types of products used. Factors associated with use were determined using multivariate regression. RESULTS: Mean age of respondents was 79.6 years; 56.4% were female, 88.8% were from Australia, 56.5% reported 12 years of education or less, and 98.7% were living at home. Two-thirds (66.2%) of participants reported use of one or more supplement/CAM in the previous month. Products most commonly used included vitamin D (33.8% of participants), fish oil (22.7%), calcium (20.6%), glucosamine (14.8%), and multivitamin (12.9%). Female sex, US residency, higher education, polypharmacy (prescription medications), and frailty (in women) were significantly associated with higher use of supplements/CAMs. CONCLUSIONS: Dietary supplement and CAM use is common among community-dwelling older adults in the United States and Australia. Given the high prevalence of use, collaboration between healthcare providers and older adult patients is important to insure safe and optimal use of these products. © 2023 The Authors. Journal of the Amer

BACKGROUND: Drug-food interactions can lead to adverse drug reactions and therapy failure which can potentially impact patient safety and therapy outcome. OBJECTIVES: This study assessed patients' knowledge, attitudes and practices regarding drug-food interactions. METHODS: A cross-sectional study was conducted among patients at three public hospitals in eThekwini, KwaZulu-Natal. Statistical analysis was performed using SPSS® version 25. The association between demographic variables and patients' knowledge, attitudes and practices were assessed. RESULTS: Of the 342 patients, 70.5% were female, and the mean age was 42.87±0.89 years. Almost 50% of patients had secondary level education, and 64% were unemployed. About 52% of patients had high knowledge of drug-food interactions; however, only 30-50% of the patients could identify potential drug-food interactions of their drugs. More than half of the patients (51.5%) answered that they took multivitamin pills with medications and 61.7% responded they consulted healthcare professionals for drug-food interactions' information before taking new medications. Few patients (15.2%) had experienced drug-food interactions. CONCLUSIONS: Overall, patients had gaps in their knowledge and practices, and positive attitudes towards drug-food interactions. Many patients could not identify food items that can potentially interact with their drugs. It is important that education and medication counselling are provided to patients to prevent drug-food interactions, ensure optimal drug therapy and patient safety. © 2022 Osuala EC et al.

PURPOSE: Patients with cancer often believe dietary supplements (DS) such as micronutrients and botanical products to be health supporting and non-toxic despite growing concerns regarding potential pharmacological interactions. Studies on the prevalence of DS use among patients with cancer are heterogeneous and mainly conducted at university-based cancer centers. This survey focused on a particular cancer patient group treated in an ambulatory setting without regular access to professional nutritional counselling. METHODS: Patients with a history of cancer or hematological malignancy were included in this survey. A self-reported questionnaire was used to evaluate the different aspects of DS use, changes in dietary habits and patients' demographic characteristics. RESULTS: Almost every second patient reported using DS (47.2%). Women (56.3%), patients with an academic degree (56.0%) and non-smokers (84.8%) were more inclined to use DS. Along with magnesium (16.6%), calcium (14.3%), multivitamins (12.0%) and vitamin C (9.4%), use of herbal supplements (12.6%) was common. Women (84.8% vs. 74.9% of men, p = < 0.001) and patients younger than 65 years (84.4% vs. 77.2% of patients > 65 y, p = 0.002) sought dietary advice more often. Support of the immune system was the main reason for DS use (26.4%) and a relevant number of patients (49.6%) reported to have changed their dietary habits following cancer diagnosis. CONCLUSION: DS use is common among patients with cancer treated in an ambulatory setting. This finding should encourage oncologists to implement detailed questioning about DS use and dietary habits to prevent potential interactions and offer substantial advice.

Nearly 70% of older adults in the U.S. report using ≥1 dietary supplements (DSs) daily. While DSs may have health benefits, there is risk for toxicity or harmful drug-supplement interactions if not taken correctly. Older adults with chronic wounds who use DSs are at increased risk of adverse drug-supplement interactions because they usually have comorbidities requiring polypharmacy management. However, no studies have evaluated DS use in this population. The aim of this retrospective pilot study was to describe DS use by a sample of older adults (n = 40) with chronic venous leg ulcers (CVLUs) who participated in a clinical trial testing the effects of fish oil supplementation on wound healing. At baseline, study personnel assisted all participants in completing an electronic questionnaire about DS use. Descriptive statistics were used to characterize the data. Twenty-five of the 40 participants (62.5%) reported taking ≥1 DS daily. On average, DS users were 65.16 years (SD = 8.51) and the majority were men (64.0%), white (68.0%), and had at least some college education (72.0%). Fifteen (60.0%) reported taking 1-2 DSs/day, and 10 (40.0%) reported taking ≥3/day. The most frequently reported DSs used were multivitamin/mineral complex (60.0%), vitamin D (36.0%), vitamin B complex (28.0%) and calcium (28.0%). Reasons for using DSs were to maintain or improve health (44.0%), improve bone density (12%), and boost the immune system (12%). Supplement users reported consuming an average of 9.12 (SD = 6.46) prescription drugs daily and 21 (84.0%) reported ≥3 chronic health conditions. In summary, DS use in this sample of chronic wound patients was high. Moreover, DS users reported using multiple prescription drugs (2-23/day) concomitantly with DSs. While older adults with CVLUs may benefit from targeted DS therapy, monitoring their DS use to reduce risk for adverse drug-supplement interactions is best practice. © 2020 by the Wound Healing Society.

PURPOSE: To study the extent and characteristics of dietary and herbal supplements use in a large cohort of adult patients with epilepsy. METHODS: This prospective study included 490 patients receiving care at a university epilepsy clinic. A number of variables, including demographics, characteristics of epilepsy and its treatment, comedication as well as data related to supplements intake were collected from medical records and a dedicated questionnaire. RESULTS: Overall 247 patients (50.4%) took at least one dietary supplement; nearly half (111, 44.9%) of this group took >1 products. Multivitamins and magnesium were the most prevalent supplements. Most of the patients used supplements for general health rather than their epilepsy condition. The average number of supplements and prescription medications used per person was 5.4. Ten percent (25 of 247) of subjects used dietary supplements which could have proconvulsive effect or potential for interaction with prescription medications. Multivariate analysis revealed two independent variables associated with supplements intake, younger age and female sex. CONCLUSION: Dietary and herbal supplements use is common in patients with epilepsy, adding to the burden of overmedication. Concurrent use of supplements may potentially lead to interactions with prescription medications or loss of seizure control. Health care providers should routinely check for dietary supplements use to limit potential harm related to their intake.

Oral and intravenous (IV) omadacycline formulations are approved in the United States for treating acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia in adults. Oral omadacycline bioavailability is 34.5%; similar exposures are obtained following 300 mg oral and 100 mg IV doses. Oral administration should be in a fasted state, with dairy products, antacids, or multivitamins avoided for ≥4 hours after dosing. Low protein binding (21%), large volume of distribution (190 L), low systemic clearance (10 L/hour), and long elimination half-life (16-17 hours) support once-daily dosing. Omadacycline is excreted unchanged in feces (81.1%) and urine (14.4%), with low potential for drug-drug interactions. Dose adjustments are unnecessary for age, sex, and renal or hepatic impairment. Pharmacokinetic-pharmacodynamic studies identify fAUC0-24/MIC ratio as the parameter that correlates with in vivo efficacy. Systemic exposure of omadacycline in epithelial lining fluid is greater than/equal to plasma concentrations in healthy adults. © The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America.

AIMS: The aim of this study was to determine whether a combination of intravitreal aflibercept (IVA) and pranoprofen eyedrops or nutraceutical support provides additional benefit over IVA monotherapy for the treatment of choroidal neovascularization (CNV) in age-related macular degeneration. METHODS: This was a prospective, randomized, pilot study in 60 patients with treatment-naïve CNV. Patients were randomized 1:1:1 into three groups: aflibercept monotherapy (AM), aflibercept plus pranoprofen (AP) or aflibercept plus nutraceutical (AN) tablets containing multivitamin antioxidant and mineral supplementation plus omega-3. RESULTS: At 12 months, all groups showed significant improvement in both best-corrected visual acuity (BCVA) and central retinal thickness (CRT). The mean BCVA change from baseline to 12 months was -0.26 ± 0.06 LogMAR, -0.30 ± 0.06 LogMAR and -0.24 ± 0.04 LogMAR in the AM, AP and AN groups, respectively. The mean CRT change from baseline to 12 months was -76.9 ± 10.9 μm, -129 ± 19.9 μm and -105 ± 11.6 μm in the AM, AP and AN groups, respectively. The AN group required one less IVA injection than the AM group. CONCLUSIONS: Compared with AM, both combination groups acted synergistically, although no significant benefits in BCVA were found over AM. Nutraceutical support with omega-3 leads to a reduced need for IVA. © 2019 The British Pharmacological Society.

This study assessed possible dietary supplement-medication interactions of 62 older adults recruited from 8 senior congregate sites in Bexar County, Texas. Dietary supplement and medication use were collected by paper questionnaire and potential supplement-medication interactions were assessed using online databases. The majority of participants reported dietary supplements (77%), non-prescription medication (50%), and prescription medication (73%) use. Fifty percent of participants who reported dietary supplement and medication use were at-risk for a potential supplement-medication interaction, ranging from one to eight potential interactions. Calcium and multivitamin-mineral supplements were the most common dietary supplements with potential medication interactions. Surveyed older adults reported dietary supplements should be reported to a physician (97%), but over 20% believe herbal products are pure (38%) and dietary supplements are risk free (34%) and will not cause harm (22%). In conclusion, regular education and screening of dietary supplement and medication use among older adults is recommended.

BACKGROUND: Polypharmacy is common among older adults, with increasing numbers also using prescription drugs with herbal medicinal products (HMPs) and dietary supplements. There is no reliable evidence from the UK on concurrent use of HMPs and dietary supplements with prescription drugs in older adults. AIM: To establish prevalence of concurrent prescription drugs, HMPs, and dietary supplements among UK community-dwelling older adults and identify potential interactions. DESIGN AND SETTING: Cross-sectional survey of older adults registered at two general practices in South East England. METHOD: A questionnaire asking about prescription medications, HMPs, and sociodemographic information was posted to 400 older adults aged ≥65 years, identified as taking ≥1 prescription drug. RESULTS: In total 155 questionnaires were returned (response rate = 38.8%) and the prevalence of concurrent HMPs and dietary supplements with prescriptions was 33.6%. Females were more likely than males to be concurrent users (43.4% versus 22.5%; P = 0.009). The number of HMPs and dietary supplements ranged from 1 to 8, (mean = 3, median = 1; standard deviation = 1.65). The majority of concurrent users (78.0%) used dietary supplements with prescription drugs. The most commonly used dietary supplements were cod liver oil, glucosamine, multivitamins, and vitamin D. Others (20.0%) used only HMPs with prescription drugs. Common HMPs were evening primrose oil, valerian, and Nytol Herbal® (a combination of hops, gentian, and passion flower). Sixteen participants (32.6%) were at risk of potential adverse drug interactions. CONCLUSION: GPs should routinely ask questions regarding herbal and supplement use, to identify and manage older adults at potential risk of adverse drug interactions. © British Journal of General Practice 2018.

PURPOSE OF REVIEW: Medications have the potential to affect nutritional status in negative ways, especially as the number of medications increase. The inter-relation between polypharmacy and malnutrition is complex and not fully delineated in previous studies. More research has been done and compiled in the last year, which helps to clarify this relationship. This review brings together the most recent literature with the previous research to help healthcare providers to better assess and manage medication therapy in older adults. RECENT FINDINGS: Recent evidence confirms a synergistic negative effect of polypharmacy and malnutrition on outcomes of older adults. In addition, several drug classes, including common antihypertensive agents, acetylcholinesterase inhibitors, multivitamins, proton pump inhibitors, HMG-CoA reductase inhibitors (statins), antiplatelet agents and metformin, have been implicated in important drug-nutrient interactions. These are reviewed in detail here. Ongoing research endeavors are described. SUMMARY: Healthcare practitioners can use this review to identify potentially inappropriate medications and patients at highest risk of experiencing a medication-related adverse reaction in order to systematically deprescribe these high-risk medications.