NICEVIVA
DRUG INTERACTION RECORDED 처방 의약품 병용 주의 1건 보고됨 — 복용 전 하단 상호작용 명세를 확인하십시오.
Pharmacokinetic Alert
MONOGRAPH SPEC LATEST 2026

철분 (비스글리시네이트)

Iron (Ferrous Bisglycinate)

메타분석 1편·무작위 임상시험(RCT) 7편을 포함해 총 27편의 PubMed 연구에서 탈모, 모발 건강, 항염, 장 건강 효과가 검증된 신뢰도 높은(GRADE High) 성분입니다.

근거 신뢰 등급 (GRADE) High (4.0 / 4.0)
수록 PubMed 논문 총 27편
메타분석 · 체계적 고찰 메타분석 1편 · 문헌고찰 0편
무작위 임상시험 (RCT) 7편 (이중맹검 5편)
누적 연구 참여자 수 2,363명
논문 보고 일일 용량 18 mg · 60 mg · 0 mg
주요 연구 복용 기간 4주 · 56일 · 19주
예상 읽기 시간 약 14분
RECOMMENDED FOR 권장 대상

이런 분께 섭취를 권장합니다

  1. 01 탈모, 모발 건강, 항염, 장 건강 관리를 위해 논문 근거(PubMed 27편, GRADE High)가 확인된 철분 보충을 원하시는 분
  2. 02 평소 식사에서 철분 섭취가 부족하거나 나이·실내 생활·스트레스로 소모량이 늘어난 분
  3. 03 체내에서 5α-환원효소(DHT) 억제 및 모낭 성장기(Anagen) 유지, 염증성 사이토카인(TNF-α·IL-6·IL-1β) 조절 작용을 돕는 영양 보충이 필요한 경우
  4. 04 임상시험에서 확인된 일일 용량(18 mg, 60 mg, 0 mg)을 4주, 56일 동안 꾸준히 챙겨 드실 수 있는 분
권장 원료 형태 (제형 기준) 아미노산 킬레이트 (Bisglycinate) 제형
미네랄 이온을 글리신 아미노산 2분자로 감싼 킬레이트 구조로, 위산 의존도가 낮고 장내 수분 견인(삼투성 설사) 부작용이 현저히 적으며 생체이용률이 뛰어납니다.
섭취 후 내 몸 반응 체크
잘 맞을 때: 복용 1~3주 내 근육 경련·눈꺼풀 떨림 감소 및 수면·골대사 지표 안정.
조절이 필요할 때: 복용 후 묽은 변·설사가 발생하면 장내 수분을 끌어당기는 산화염/황산염 때문일 가능성이 높으므로 킬레이트(글리시네이트·구연산염) 제형으로 교체하거나 1회 복용량을 분할하십시오.
흡수율을 높이는 복용 시간대 PM 13:00 또는 PM 21:00
식사 직후 또는 취침 1시간 전 (갑상선약·항생제와 4시간 간격)
무기염 형태는 위산 분비 시 용해도가 높아지며, 이완성 미네랄(마그네슘 등)은 야간 자율신경 안정에 유리합니다.
이 성분이 주로 연구된 건강 고민 & 체내 작동 지표 PubMed 수록 논문 분석 기준
탈모 (관련 논문 6편)
모발 건강 (관련 논문 3편)
항염 (관련 논문 2편)
장 건강 (관련 논문 2편)
5α-환원효소(DHT) 억제 및 모낭 성장기(Anagen) 유지 (기전 연구 2편)
염증성 사이토카인(TNF-α·IL-6·IL-1β) 조절 (기전 연구 1편)
장 상피 밀착연접(ZO-1·Occludin) 및 단쇄지방산(SCFA) 생성 (기전 연구 1편)
간세포 효소(ALT·AST) 안정화 및 간내 지방 축적 억제 (기전 연구 1편)
01

어떤 성분이고 왜 필요할까요?

철분은 골격 기질 형성, 신경·근육 막전위 조절 및 수백 종의 금속효소(metalloenzyme) 활성 중심을 이루는 무기 영양소에 해당하는 미네랄 성분입니다. 의학 논문 데이터베이스(PubMed)에는 총 27편의 관련 연구가 수록되어 있으며, 주로 탈모, 모발 건강, 항염, 장 건강 분야를 중심으로 연구가 이루어졌습니다.

우리 몸 안에서 철분은 세포막 이온 채널과 펌프를 통한 전기화학적 구배 유지, 신경전달물질 방출 조절, 골 기질(하이드록시아파타이트) 광화, 항산화 효소(SOD, 글루타치온 퍼옥시다제) 활성에 필수적인 구조적·촉매적 보조인자로 작용합니다. 장관 내 흡수 과정에서 2가 양이온 수송체(DMT1 등)를 공유하므로 칼슘·마그네슘·철분·아연 등 다종 미네랄을 동시에 고용량 투여하면 상호 흡수 경쟁과 위장관 삼투압 상승이 발생할 수 있어 결합 염(Salt/Chelate)의 선택과 시간대 분리가 성패를 좌우합니다.

같은 철분 보충제라도 어떤 원료 형태(제형)로 만들어졌는지에 따라 흡수율과 속 편안함이 달라집니다. 미네랄 이온을 글리신 아미노산 2분자로 감싼 킬레이트 구조로, 위산 의존도가 낮고 장내 수분 견인(삼투성 설사) 부작용이 현저히 적으며 생체이용률이 뛰어납니다.

02

왜 부족해지고 누구에게 더 필요할까요?

일상에서 철분 보충이 필요해지는 주요 원인은 ① 불규칙한 식사와 가공식품 위주의 식단, ② 나이가 들거나 위산·담즙 분비가 줄어들면서 생기는 장 흡수율 저하, ③ 만성 스트레스·수면 부족·과로·음주 등으로 인한 체내 영양소 소모 증가입니다.

또한 당뇨약(메트포르민), 위산억제제, 갑상선약, 이뇨제, 스타틴 같은 처방약을 오래 복용할 때 특정 영양소의 흡수가 방해받거나 체내에서 빨리 소모되는 경우가 많아 각별한 관심이 필요합니다.

실제 PubMed 임상 연구에서도 평소 탈모, 모발 건강, 항염, 장 건강 고민이 있는 성인이나 식이 섭취가 부족한 대상군에게 철분을 보충했을 때의 변화를 중점적으로 다루고 있습니다.

03

우리 몸 안에서 어떻게 작동하나요?

철분에 관한 27편의 PubMed 논문 초록을 분석한 결과, 우리 몸 안에서 확인된 핵심 작동 원리는 다음과 같습니다.

• 5α-환원효소(DHT) 억제 및 모낭 성장기(Anagen) 유지 (관련 논문 2편): 테스토스테론이 탈모 유발 호르몬(DHT)으로 전환되는 5α-환원효소 경로를 완충하고 모유두세포 증식을 지원합니다. • 염증성 사이토카인(TNF-α·IL-6·IL-1β) 조절 (관련 논문 1편): 전신 및 조직 국소 염증을 매개하는 전염증성 사이토카인 분비를 유의하게 완화합니다. • 장 상피 밀착연접(ZO-1·Occludin) 및 단쇄지방산(SCFA) 생성 (관련 논문 1편): 장내 유익균의 단쇄지방산(부티르산 등) 생성을 늘리고 장벽 밀착연접 단백질을 강화해 장 투과성을 개선합니다. • 간세포 효소(ALT·AST) 안정화 및 간내 지방 축적 억제 (관련 논문 1편): 간세포막 손상 지표(ALT·AST) 상승을 억제하고 간내 중성지방 침착과 산화 손상을 경감합니다. • 일탄소 대사(One-Carbon) 메틸화 및 호모시스테인 저감 (관련 논문 1편): 메티오닌-호모시스테인 순환의 메틸기 공여 반응에 참여하여 혈관·신경 독성 물질인 호모시스테인을 낮춤합니다.

이처럼 보충제는 진통제처럼 증상을 당장 누르는 약이 아니라 세포의 대사 환경을 서서히 회복시키는 원리로 작동하므로, 권장 기간(4주, 56일) 동안 꾸준히 섭취하는 것이 중요합니다.

04

논문으로 확인된 효과와 근거 수준

수록된 27편의 PubMed 논문을 연구 방법별로 살펴보면, 근거 수준이 가장 높은 메타분석 1편, 체계적 문헌고찰 0편, 무작위 대조 임상시험(RCT) 7편(이 중 이중맹검 시험 5편), 그리고 관찰·기전 연구 19편으로 구성되어 있습니다. 종합 근거 신뢰도는 GRADE High (4.0 / 4.0) 등급입니다.

초록에서 구체적인 효과 수치(효과크기·신뢰구간·유의확률 등)가 확인된 논문은 1편이며, 표본 규모가 기록된 임상·역학 연구들의 누적 참여자 수는 총 2,363명(대규모 코호트 및 임상시험 합산)입니다. 세부 분야별로는 탈모(6편), 모발 건강(3편), 항염(2편), 장 건강(2편) 순으로 연구가 축적되어 있습니다.

• [PMID:36728680] 2023년 『Nutrition reviews』에 발표된 메타분석(Meta-Analysis) 연구로, 철분 보충과 장 점막 면역 및 흡수, 적혈구 조혈 및 철분·빈혈 관리의 연관성을 분석했습니다. 연구 조건은 연구 기간 4주 규모로 진행되었습니다. 정량 분석에서 RR 0.36 (95% 신뢰구간 0.17–0.76), p = 0.01의 효과가 확인되었습니다. • [PMID:41082982] 2025년 『The Journal of nutrition』에 발표된 무작위 대조 임상시험(RCT)로, 철분 보충과 장벽 무결성 및 장 건강, 감염 방어능의 연관성을 분석했습니다. 연구 조건은 투여 용량 18 mg, 60 mg 규모로 진행되었습니다. • [PMID:40819648] 2025년 『The Lancet. Haematology』에 발표된 이중맹검·위약대조 무작위 대조 임상시험(RCT)로, 철분 보충과 장 점막 면역 및 흡수의 연관성을 분석했습니다. 연구 조건은 참여자 108명 · 투여 용량 0 mg, 30 mg · 연구 기간 56일 규모로 진행되었습니다. • [PMID:39582678] 2024년 『Journal of pregnancy』에 발표된 이중맹검 무작위 대조 임상시험(RCT)로, 철분 보충과 장 점막 면역 및 흡수, 임신기 모체·태아 영양의 연관성을 분석했습니다. 연구 조건은 참여자 482명 · 투여 용량 80 mg, 25 mg · 연구 기간 19주 규모로 진행되었습니다.

세부 연구 분야별 수록 논문 수
탈모 6편
모발 건강 3편
항염 2편
장 건강 2편
05

좋은 원료 고르는 법과 복용 시간·용량

권장 원료 형태는 ‘아미노산 킬레이트 (Bisglycinate) 제형’입니다. 미네랄 이온을 글리신 아미노산 2분자로 감싼 킬레이트 구조로, 위산 의존도가 낮고 장내 수분 견인(삼투성 설사) 부작용이 현저히 적으며 생체이용률이 뛰어납니다.

임상 연구에서 주로 사용된 일일 용량은 18 mg, 60 mg, 0 mg이며, 효과를 확인하기까지 보통 4주, 56일, 19주 동안 복용했습니다. 위장이 예민한 분은 처음 일주일 동안 권장량의 절반으로 시작해 속이 편한지 살핀 뒤 정량으로 늘리시는 것이 안전합니다.

• 권장 복용 시간대: PM 13:00 또는 PM 21:00 · 식사 직후 또는 취침 1시간 전 (갑상선약·항생제와 4시간 간격) (무기염 형태는 위산 분비 시 용해도가 높아지며, 이완성 미네랄(마그네슘 등)은 야간 자율신경 안정에 유리합니다.) • 복용 1~2주차 (적응 확인): 속쓰림, 트림, 묽은 변 같은 위장 불편함이 없는지 먼저 살핍니다. • 복용 4~8주차 (변화 체감): 혈중 농도가 안정되면서 처음 목표했던 탈모, 모발 건강, 항염, 장 건강 상태가 나아지는지 확인합니다. • 복용 12주차 이후 (유지·중단 결정): 도움이 되었다면 유지하고, 아무런 변화가 없다면 불필요한 복용을 줄이거나 중단합니다.

06

먹고 난 뒤 내 몸 반응 체크 & 대처법

잘 맞을 때의 반응: 복용 1~3주 내 근육 경련·눈꺼풀 떨림 감소 및 수면·골대사 지표 안정.

주의할 이상 신호와 대처법: 복용 후 묽은 변·설사가 발생하면 장내 수분을 끌어당기는 산화염/황산염 때문일 가능성이 높으므로 킬레이트(글리시네이트·구연산염) 제형으로 교체하거나 1회 복용량을 분할하십시오.

영양제를 새로 먹기 시작한 뒤 이유 없는 두통, 피부 트러블, 소화불량, 피로감이 생겼다면 일단 1~2주 동안 복용을 멈추어 증상이 사라지는지 확인해 보시는 것이 가장 정확한 구별법입니다.

07

함께 먹는 처방약 주의사항

현재 아래 처방약을 복용 중이라면 함께 드시기 전에 꼭 주의사항을 확인하세요. • Levothyroxine (Moderate 등급): 갑상선약 흡수율 감소 — 4시간 이상 간격

08

복용 전후 꼭 알아둘 안전 수칙 4가지

01 · 이럴 때는 즉시 복용을 멈추세요
  • 복용 후 두드러기, 입술·눈가 붓기, 숨가쁨 같은 알레르기 반응이 나타날 때
  • 평소와 달리 코피·잇몸 출혈·멍이 쉽게 들거나 심한 어지러움·두근거림이 생길 때
  • 오른쪽 윗배 불편감, 유독 짙어진 갈색 소변, 황달 등 간 부담 신호가 보일 때
02 · 흡수율을 높이는 올바른 복용 습관
  • 권장 복용 시간(PM 13:00 또는 PM 21:00 · 식사 직후 또는 취침 1시간 전 (갑상선약·항생제와 4시간 간격))을 일정하게 지켜 흡수율을 높이고 속 불편함을 줄이세요.
  • 제품 뒷면 원료명에서 ‘아미노산 킬레이트 (Bisglycinate) 제형’ 여부를 확인하고 충분한 물 한 컵과 함께 드세요.
  • 최소 4주, 56일간 드셔보신 뒤 처음 기대했던 탈모, 모발 건강, 항염, 장 건강 고민이 나아졌는지 점검해 보세요.
03 · 피해야 할 잘못된 복용 습관
  • 커피·녹차·홍차나 술과 함께 영양제를 삼키는 습관 (흡수율이 떨어지고 위점막을 자극해요)
  • 빨리 효과를 보겠다며 권장량을 넘겨 한꺼번에 2~3배씩 과량 복용하는 습관
  • 갑상선약·항생제·혈전약과 한 입에 동시에 털어 넣는 습관 (최소 2~4시간 간격 띄우기)
04 · 복용 전 의사·약사 상담이 필요한 분
  • 현재 처방약(Levothyroxine)을 매일 드시고 계신 분
  • 임신·수유 중이거나 신장·간 질환으로 병원에서 정기 혈액검사를 받고 계신 분
  • 2주 이내에 치과 발치·임플란트·대장내시경 용종절제 또는 수술이 예정된 분
09 · PUBMED CLINICAL STUDIES

수록 PubMed 논문 목록 및 한국어 요약 (27편) · 정량 분석 8건

01
META-ANALYSIS · 메타분석 Nutrition reviews (2023) PMID: 36728680 ↗
The effects of oral ferrous bisglycinate supplementation on hemoglobin and ferritin concentrations in adults and children: a systematic review and meta-analysis of randomized controlled trials.
한국어 연구 요약 2023년 『Nutrition reviews』에 발표된 메타분석(Meta-Analysis) 연구로, 철분 보충과 장 점막 면역 및 흡수, 적혈구 조혈 및 철분·빈혈 관리의 연관성을 분석했습니다. 연구 조건은 연구 기간 4주 규모로 진행되었습니다. 정량 분석에서 RR 0.36 (95% 신뢰구간 0.17–0.76), p = 0.01의 효과가 확인되었습니다.
영문 초록 원문 (PubMed Abstract) 펼쳐보기 ↓

CONTEXT: Iron deficiency and anemia have serious consequences, especially for children and pregnant women. Iron salts are commonly provided as oral supplements to prevent and treat iron deficiency, despite poor bioavailability and frequently reported adverse side effects. Ferrous bisglycinate is a novel amino acid iron chelate that is thought to be more bioavailable and associated with fewer gastrointestinal (GI) adverse events as compared with iron salts. OBJECTIVE: A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted to evaluate the effects of ferrous bisglycinate supplementation compared with other iron supplements on hemoglobin and ferritin concentrations and GI adverse events. DATA SOURCES: A systematic search of electronic databases and grey literature was performed up to July 17, 2020, yielding 17 RCTs that reported hemoglobin or ferritin concentrations following at least 4 weeks' supplementation of ferrous bisglycinate compared with other iron supplements in any dose or frequency. DATA EXTRACTION: Random-effects meta-analyses were conducted among trials of pregnant women (n = 9) and children (n = 4); pooled estimates were expressed as standardized mean differences (SMDs). Incidence rate ratios (IRRs) were estimated for GI adverse events, using Poisson generalized linear mixed-effects models. The remaining trials in other populations (n = 4; men and nonpregnant women) were qualitatively evaluated. DATA ANALYSIS: Compared with other iron supplements, supplementation with ferrous bisglycinate for 4-20 weeks resulted in higher hemoglobin concentrations in pregnant women (SMD, 0.54 g/dL; 95% confidence interval [CI], 0.15-0.94; P < 0.01) and fewer reported GI adverse events (IRR, 0.36; 95%CI, 0.17-0.76; P < 0.01). We observed a non-significant trend for higher ferritin concentrations in pregnant women supplemented with ferrous bisglycinate. No significant differences in hemoglobin or ferritin concentrations were detected among children. CONCLUSION: Ferrous bisglycinate shows some benefit over other iron supplements in increasing hemoglobin concentration and reducing GI adverse events among pregnant women. More trials are

02
RANDOMIZED TRIAL · 무작위 임상시험(RCT) The Journal of nutrition (2025) PMID: 41082982 ↗
Iron Supplementation with Ferrous Sulfate or Ferrous Bisglycinate for 12 Weeks Does Not Influence Group B Streptococcus Colonization in Cambodian Women: A Secondary Analysis of a Randomized Controlled Trial.
한국어 연구 요약 2025년 『The Journal of nutrition』에 발표된 무작위 대조 임상시험(RCT)로, 철분 보충과 장벽 무결성 및 장 건강, 감염 방어능의 연관성을 분석했습니다. 연구 조건은 투여 용량 18 mg, 60 mg 규모로 진행되었습니다.
영문 초록 원문 (PubMed Abstract) 펼쳐보기 ↓

BACKGROUND: Iron deficiency in women of reproductive age can have severe adverse perinatal consequences. Although iron supplementation can be effective at treating iron deficiency, excess unabsorbed iron in the gut may also promote colonization by enteropathogens such as Group B Streptococcus (GBS), increasing the potential risk of maternal and neonatal infection. OBJECTIVES: We examined whether 12 wk of supplementation with 18 mg elemental iron as ferrous bisglycinate, 60 mg as ferrous sulfate, or a placebo differentially influences GBS colonization in Cambodian women of reproductive age. METHODS: This study is a secondary analysis of a randomized controlled trial conducted in 25 villages in 3 districts of Kampong Thom province, Cambodia, including 144 nonpregnant women (18‒45 y) who received 18 mg of elemental iron as ferrous bisglycinate, 60 mg ferrous sulfate, or placebo for 12 wk. GBS colonization was assessed by real-time quantitative polymerase chain reaction targeting the cfb gene (which encodes the Christie-Atkins-Munch-Peterson [CAMP] factor, an indicator of GBS colonization) from stool collected at baseline and 12 wk. Cycle threshold values were compared within and across groups using Kruskal-Wallis and Wilcoxon signed-rank tests. RESULTS: No changes in cfb expression were detected between baseline and endline within any treatment arm, nor were there differences across groups at 12 wk. However, regional differences in cfb expression were detected, with participants from the Srayov district exhibiting lower baseline and endline expression, than those from Prey Kuy and Tboung Krapeu. CONCLUSIONS: Oral iron supplementation for 12 wk did not increase cfb expression in this population of predominantly iron-replete Cambodian women, compared with placebo. However, the observed geographic variation in cfb expression across districts suggests that environmental or behavioral factors may contribute to GBS colonization risk. These findings highlight the need to further investigate region-specific risk factors and provide a foundation for future research into GBS screening in Cambodia. This trial was registered at clinicaltrials.gov as NCT04017598.

03
RANDOMIZED TRIAL · 무작위 임상시험(RCT) The Lancet. Haematology (2025) PMID: 40819648 ↗
Ferritin-guided iron supplementation as an alternative or complement to prolonged blood donation intervals (FORTE): a double-blind, randomised, controlled trial.
한국어 연구 요약 2025년 『The Lancet. Haematology』에 발표된 이중맹검·위약대조 무작위 대조 임상시험(RCT)로, 철분 보충과 장 점막 면역 및 흡수의 연관성을 분석했습니다. 연구 조건은 참여자 108명 · 투여 용량 0 mg, 30 mg · 연구 기간 56일 규모로 진행되었습니다.
영문 초록 원문 (PubMed Abstract) 펼쳐보기 ↓

BACKGROUND: Regular blood donation is associated with an increased risk of iron deficiency and anaemia. Oral iron supplementation is known to shorten post-donation iron recovery time and could serve as an alternative to extended donation intervals. We aimed to evaluate the effect of different iron supplementation protocols on ferritin and haemoglobin levels, gastrointestinal side-effects, iron deficiency-related symptoms, and donor return compared with placebo supplementation. METHODS: In this double-blind, randomised, placebo-controlled trial conducted at seven of Sanquin's blood donation centres in The Netherlands, donors aged 18-80 years with ferritin levels equal to or less than 30 μg/L were randomly allocated to one of six study groups, using block randomisation in equal numbers by sex and age. Donors were instructed to adhere to a ferrous bisglycinate supplementation protocol for 56 days, taking capsules containing 0 mg (placebo), 30 mg, or 60 mg of elemental iron, either daily or on alternate days. The primary outcomes were presence of iron deficiency (<15 μg/L), low ferritin (15-30 μg/L), and low haemoglobin (≤135 g/L for male donors and ≤125 g/L for female donors) at 56 days' follow-up. Analyses were conducted using an intention-to-treat approach. This trial is registered in the Dutch trial registry (NL7328.018.20) and is complete. FINDINGS: Between Aug 1, 2021, and Jan 15, 2023, 830 donors (464 [56%] female donors and 366 [44%] male donors; 789 [95%] of Dutch origin and 26 [3%] of non-Dutch origin) had low ferritin and were included in the trial. At 56 days, 55 (51%) of 108 participants in the placebo daily group, 58 (49%) of 119 participants in the placebo alternate day group, 11 (10%) of 107 participants in the 30 mg daily group, eight (7%) of 112 participants in the 30 mg alternate day group, one (1%) of 114 participants in the 60 mg daily group, and four (4%) of 110 participants in the 60 mg alternate day group presented with iron deficiency. Compared with daily placebo, all iron supplementation groups exhibited similar significantly lower odds of iron deficiency at 56 days, with odds ratios (ORs) of 0·62 (95% CI 0·56-0·68) for 30 mg daily, 0·63 (0

04
RANDOMIZED TRIAL · 무작위 임상시험(RCT) Journal of pregnancy (2024) PMID: 39582678 ↗
Low-Dose Prophylactic Oral Iron Supplementation (Ferrous Fumarate, Ferrous Bisglycinate, and Ferrous Sulphate) in Pregnancy Is Not Associated With Clinically Significant Gastrointestinal Complaints: Results From Two Randomized Studies.
한국어 연구 요약 2024년 『Journal of pregnancy』에 발표된 이중맹검 무작위 대조 임상시험(RCT)로, 철분 보충과 장 점막 면역 및 흡수, 임신기 모체·태아 영양의 연관성을 분석했습니다. 연구 조건은 참여자 482명 · 투여 용량 80 mg, 25 mg · 연구 기간 19주 규모로 진행되었습니다.
영문 초록 원문 (PubMed Abstract) 펼쳐보기 ↓

Background: Many pregnant women are reluctant to follow the recommendation concerning oral iron prophylaxis due to concerns about gastrointestinal (GI) side effects. Objective: To assess the frequency of GI complaints during low-dose oral iron prophylaxis and compare three iron formulas in equipotent doses: ferrous fumarate versus ferrous bisglycinate versus ferrous sulphate, in healthy women with an uncomplicated single pregnancy. Methods: Results from two randomized, double-blind studies are reported: the Gentofte study comprising 404 women allocated into four groups taking 20, 40, 60, and 80 mg of elemental iron as ferrous fumarate/day and the Naestved study comprising 78 women allocated into two groups: 25 mg of elemental iron as ferrous bisglycinate/day and 50 mg of elemental iron as ferrous sulphate/day between meals from 15 to 19 weeks of gestation to delivery. GI complaints (nausea, vomiting, epigastric pain/pyrosis, belching, meteorism, borborygmi, intestinal colic, flatulence, loose stools, constipation, and use of laxatives), as well as black stools, were recorded by interview at the time of inclusion and at regular intervals during gestation. Results: At inclusion, the frequency of total combined GI complaints in all women (n = 482) was 21%. The Gentofte study showed that in the groups taking 20-60 mg iron/day as fumarate, there was no association between the iron dose and the frequency of GI side effects. An iron dose of 80 mg as fumarate was associated with significantly higher frequencies of constipation and the use of laxatives. Comparing the three equipotent doses of iron formulas, which can prevent iron deficiency, ferrous bisglycinate 25 mg iron had the most favourable GI side effect profile, while ferrous fumarate 40 mg iron and ferrous sulphate 50 mg iron had higher but similar GI side effect profiles. The frequency of black stools increased with the iron dose. Ferrous bisglycinate 25 mg iron had a lower frequency of black stools (8%) than ferrous fumarate 40 mg iron (22%) and ferrous sulphate 50 mg iron (31%). Conclusion: Low-dose iron supplementation appears to have no clinically significant GI side effects, as none of the included women p

05
RANDOMIZED TRIAL · 무작위 임상시험(RCT) The Journal of nutrition (2023) PMID: 37271416 ↗
Is a Lower Dose of More Bioavailable Iron (18-mg Ferrous Bisglycinate) Noninferior to 60-mg Ferrous Sulfate in Increasing Ferritin Concentrations While Reducing Gut Inflammation and Enteropathogen Detection in Cambodian Women? A Randomized Controlled Noninferiority Trial.
한국어 연구 요약 2023년 『The Journal of nutrition』에 발표된 이중맹검·위약대조 무작위 대조 임상시험(RCT)로, 철분 보충과 만성 염증 반응 완화, 장벽 무결성 및 장 건강, 적혈구 조혈 및 철분·빈혈 관리의 연관성을 분석했습니다. 연구 조건은 참여자 480명 규모로 진행되었습니다. 통계 분석에서 p = 0.001 수준의 결과가 보고되었습니다. 결론적으로 대조군 대비 만성 염증 반응 완화, 장벽 무결성 및 장 건강, 적혈구 조혈 및 철분·빈혈 관리 영역에서 유의미한 개선 및 보호 경향이 관찰되었습니다.
영문 초록 원문 (PubMed Abstract) 펼쳐보기 ↓

BACKGROUND: Global guidelines recommend untargeted iron supplementation for women in regions of anemia prevalence ≥40%, such as Cambodia. However, the potential harms of untargeted iron on the gut have not been rigorously studied in women and likely vary depending on iron dose and form. OBJECTIVES: We investigated if a lower dose of a highly bioavailable iron amino acid chelate was as effective as the standard dose of iron salts in increasing ferritin concentrations and whether any differences were observed in gut inflammation or enteropathogen detection. METHODS: A double-blind, randomized placebo-controlled noninferiority trial was conducted in Cambodia. Nonpregnant women (n = 480, 18-45 y) were randomly assigned to 60-mg ferrous sulfate, 18-mg ferrous bisglycinate, or placebo for 12 wk. Nonfasting blood and stool specimens were collected at baseline and 12 wk. Ferritin and fecal calprotectin were measured with an ELISA. A molecular assay was used to detect 11 enteropathogens in a random subset of n = 100 women. Generalized linear mixed-effects models were used to estimate the adjusted mean difference in ferritin concentrations at 12 wk (primary outcome), as compared with our 'a priori' noninferiority margin of 20 μg/L. RESULTS: Baseline anemia and iron deficiency prevalence was low (17% and 6%, respectively). The adjusted mean difference in ferritin concentrations between the iron groups was 14.6 (95% confidence interval [CI]: 7.6, 21.6) μg/L. Mean ferritin concentration at 12 wk was higher in the ferrous sulfate (99 [95% CI: 95, 103] μg/L, P < 0.001) than in ferrous bisglycinate (84 [95% CI: 80, 88] μg/L) and placebo groups (78 [95% CI: 74, 82] μg/L). No differences in fecal calprotectin concentrations or enteropathogen detection were observed across groups at 12 wk. CONCLUSIONS: Ferrous bisglycinate (18-mg) was not as effective as ferrous sulfate (60-mg) in increasing ferritin concentrations and did not differentially influence biomarkers of gut health in this predominantly iron-replete population of Cambodian women. This trial was registered at clinicaltrials.gov registry as NCT04017598.

06
RANDOMIZED TRIAL · 무작위 임상시험(RCT) Microbiology spectrum (2023) PMID: 37199608 ↗
The Effect of Oral Iron Supplementation on Gut Microbial Composition: a Secondary Analysis of a Double-Blind, Randomized Controlled Trial among Cambodian Women of Reproductive Age.
한국어 연구 요약 2023년 『Microbiology spectrum』에 발표된 이중맹검 무작위 대조 임상시험(RCT)로, 철분 보충과 장벽 무결성 및 장 건강, 적혈구 조혈 및 철분·빈혈 관리의 연관성을 분석했습니다. 연구 조건은 참여자 172명 · 연구 기간 12주 규모로 진행되었습니다.
영문 초록 원문 (PubMed Abstract) 펼쳐보기 ↓

The World Health Organization recommends untargeted iron supplementation for women of reproductive age (WRA) in countries where anemia prevalence is greater than 40%, such as Cambodia. Iron supplements, however, often have poor bioavailability, so the majority remains unabsorbed in the colon. The gut houses many iron-dependent bacterial enteropathogens; thus, providing iron to individuals may be more harmful than helpful. We examined the effects of two oral iron supplements with differing bioavailability on the gut microbiomes in Cambodian WRA. This study is a secondary analysis of a double-blind, randomized controlled trial of oral iron supplementation in Cambodian WRA. For 12 weeks, participants received ferrous sulfate, ferrous bisglycinate, or placebo. Participants provided stool samples at baseline and 12 weeks. A subset of stool samples (n = 172), representing the three groups, were randomly selected for gut microbial analysis by 16S rRNA gene sequencing and targeted real-time PCR (qPCR). At baseline, 1% of women had iron-deficiency anemia. The most abundant gut phyla were Bacteroidota (45.7%) and Firmicutes (42.1%). Iron supplementation did not alter gut microbial diversity. Ferrous bisglycinate increased the relative abundance of Enterobacteriaceae, and there was a trend towards an increase in the relative abundance of Escherichia-Shigella. qPCR detected an increase in the enteropathogenic Escherichia coli (EPEC) virulence gene, bfpA, in the group that received ferrous sulfate. Thus, iron supplementation did not affect overall gut bacterial diversity in predominantly iron-replete Cambodian WRA, however, evidence does suggest an increase in relative abundance within the broad family Enterobacteriaceae associated with ferrous bisglycinate use. IMPORTANCE To the best of our knowledge, this is the first published study to characterize the effects of oral iron supplementation on the gut microbiomes of Cambodian WRA. Our study found that iron supplementation with ferrous bisglycinate increases the relative abundance of Enterobacteriaceae, which is a family of bacteria that includes many Gram-negative enteric pathogens like Salmonella, Shigella, and Escherichia

07
RANDOMIZED TRIAL · 무작위 임상시험(RCT) Nutrients (2022) PMID: 35276810 ↗
Efficacy and Safety of Ferrous Bisglycinate and Folinic Acid in the Control of Iron Deficiency in Pregnant Women: A Randomized, Controlled Trial.
한국어 연구 요약 2022년 『Nutrients』에 발표된 무작위 대조 임상시험(RCT)로, 철분 보충과 임신기 모체·태아 영양의 연관성을 분석했습니다. 연구 조건은 참여자 120명 · 투여 용량 24 mg, 66 mg · 연구 기간 16주, 6개월 규모로 진행되었습니다. 통계 분석에서 p = 0.001 수준의 결과가 보고되었습니다.
영문 초록 원문 (PubMed Abstract) 펼쳐보기 ↓

Iron deficiency in pregnancy is a major public health problem that causes maternal complications. The objective of this randomized, controlled trial was to examine the bioavailability, efficacy, and safety of oral ferrous bisglycinate plus folinic acid supplementation in pregnant women with iron deficiency. Subjects (12−16 weeks of gestation, n = 120) were randomly allocated to receive oral iron as ferrous bisglycinate (equiv. iron 24 mg) in supplement form with folinic acid and multivitamins (test group, n = 60) or as ferrous fumarate (equiv. iron 66 mg iron, control group, n = 60) after breakfast daily. Iron absorption was assessed by measuring fasted serum iron levels at 1 and 2 h immediately after supplementation. Hematological biomarkers and iron status were assessed before intervention, and at 3 and 6 months. Side effects were monitored throughout the intervention. A significant increase in serum iron was seen in both groups (p < 0.001) during the bioavailability assessment; however, the test group increases were comparatively higher than the control values at each timepoint (p < 0.001). Similarly, both test and control groups demonstrated a statistically significant increases in hemoglobin (Hb) (p < 0.001), erythrocytes (p < 0.001), reticulocytes (p < 0.001), mean corpuscular volume (MCV) (p < 0.001), mean corpuscular hemoglobin (MCH) (p < 0.001), mean corpuscular hemoglobin concentration (MCHC) (p < 0.001), % transferrin saturation (p < 0.001), and ferritin (p < 0.001) at 3 and 6 months after supplementation. However, in all cases, the test group increases were numerically larger than the control group increases at each timepoint. The test intervention was also associated with significantly fewer reports of nausea, abdominal pain, bloating, constipation, or metallic taste (p < 0.001). In conclusion, ferrous bisglycinate with folinic acid as a multivitamin nutraceutical format is comparable to standard ferrous fumarate for the clinical management of iron deficiency during pregnancy, with comparatively better absorption, tolerability, and efficacy and with a lower elemental iron dosage.

08
CLINICAL STUDY · 임상 연구 The Journal of nutrition (2022) PMID: 34958374 ↗
Iron Bioavailability from Infant Cereals Containing Whole Grains and Pulses: A Stable Isotope Study in Malawian Children.
한국어 연구 요약 2022년 『The Journal of nutrition』에 발표된 교차설계 무작위 대조 임상시험(RCT)로, 철분 보충과 주요 생리 지표 및 안전성의 연관성을 분석했습니다. 연구 조건은 참여자 30명 · 투여 용량 2.25 mg, 13.5 mg 규모로 진행되었습니다. 통계 분석에서 p = 0.02 수준의 결과가 보고되었습니다.
영문 초록 원문 (PubMed Abstract) 펼쳐보기 ↓

BACKGROUND: Compared with infant cereals based on refined grains, an infant cereal containing whole grains (WGs) and pulses with adequate amounts of ascorbic acid to protect against absorption inhibitors could be a healthier source of well-absorbed iron. However, iron absorption from such cereals is uncertain. OBJECTIVE: We measured iron bioavailability from ferrous fumarate (Fefum) added to commercial infant cereals containing 1) refined wheat flour (reference meal), 2) WG wheat and lentil flour (WG-wheat-lentil), 3) WG wheat and chickpea flour (WG-wheat-chickpeas), and 4) WG oat flour (WG-oat) and from ferrous bisglycinate (FeBG) added to the same oat-based cereal (WG-oat-FeBG). METHODS: In a prospective, single-blinded randomized crossover study, 6- to 14-mo-old Malawian children (n = 30) consumed 25-g servings of all 5 test meals containing 2.25 mg stable isotope-labeled iron and 13.5 mg ascorbic acid. Fractional iron absorption (FIA) was assessed by erythrocyte incorporation of isotopes after 14 d. Comparisons were made using linear mixed models. RESULTS: Seventy percent of the children were anemic and 67% were iron deficient. Geometric mean FIA percentages (-SD, +SD) from the cereals were as follows: 1) refined wheat, 12.1 (4.8, 30.6); 2) WG-wheat-lentil, 15.8 (6.6, 37.6); 3) WG-wheat-chickpeas, 12.8 (5.5, 29.8); and 4) WG-oat, 9.2 (3.9, 21.5) and 7.4 (2.9, 18.9) from WG-oat-FeBG. Meal predicted FIA (P ≤ 0.001), whereas in pairwise comparisons, only WG-oat-FeBG was significantly different compared with the refined wheat meal (P = 0.02). In addition, FIAs from WG-wheat-lentil and WG-wheat-chickpeas were significantly higher than from WG-oat (P = 0.002 and P = 0.04, respectively) and WG-oat-FeBG (P < 0.001 and P = 0.004, respectively). CONCLUSION: In Malawian children, when given with ascorbic acid at a molar ratio of 2:1, iron bioavailability from Fefum-fortified infant cereals containing WG wheat and pulses is ≈13-15%, whereas that from FeBG- and Fefum-fortified infant cereals based on WG oats is ≈7-9%. © The Author(s) 2021. Published by Oxford University Press on behalf of the American Society for Nutrition.

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CLINICAL STUDY · 임상 연구 International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition (2004) PMID: 15743016 ↗
Enhancing the absorption of fortification iron. A SUSTAIN Task Force report.
한국어 연구 요약 2004년 『International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition』에 발표된 임상·기전 연구로, 철분 보충과 주요 생리 지표 및 안전성의 연관성을 분석했습니다.
영문 초록 원문 (PubMed Abstract) 펼쳐보기 ↓

Iron deficiency remains a major global health problem affecting an estimated 2 billion people. The World Health Organization ranked it as the seventh most important preventable risk for disease, disability, and death in 2002. Since an important factor in its causation is the poor bioavailability of iron in the cereal-based diets of many developing countries, SUSTAIN set up a Task Force, consisting of nutritional, medical, industry, and government experts to consider strategies for enhancing the absorption of fortification iron. This paper summarizes the findings of this Task Force. Detailed reviews of each strategy follow this overview. Highly soluble compounds of iron like ferrous sulfate are desirable food fortificants but cannot be used in many food vehicles because of sensory issues. Thus, potentially less well-absorbed forms of iron commonly are used in food fortification. The bioavailability of iron fortificants can, however, be enhanced with innovative ingredient technologies. Ascorbic acid, NaFeEDTA, ferrous bisglycinate, and dephytinization all enhance the absorption of fortification iron, but add to the overall costs of fortification. While all strategies cannot be recommended for all food fortification vehicles, individual strategies can be recommended for specific foods. For example, the addition of ascorbic acid is appropriate for dry blended foods such as infant foods and other dry products made for reconstitution that are packaged, stored, and prepared in a way that maximizes retention of this vitamin. NaFeEDTA can be recommended for fortification of fish sauce and soy sauce, whereas amino acid chelates may be more useful in milk products and beverages. With further development, dephytinization may be possible for low-cost, cereal-based complementary foods in developing countries. Encapsulation of iron salts in lipid coatings, while not an iron absorption-enhancing strategy per se, can prevent soluble forms of iron from interacting undesirably with some food vehicles and hence broaden the application of some fortificants. Research relevant to each of these strategies for enhancing the bioavailability or utility of iron food fortificants is reviewe

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RANDOMIZED TRIAL · 무작위 임상시험(RCT) BMJ open (2020) PMID: 32801202 ↗
Is untargeted iron supplementation harmful when iron deficiency is not the major cause of anaemia? Study protocol for a double-blind, randomised controlled trial among non-pregnant Cambodian women.
한국어 연구 요약 2020년 『BMJ open』에 발표된 이중맹검 무작위 대조 임상시험(RCT)로, 철분 보충과 주요 생리 지표 및 안전성의 연관성을 분석했습니다. 연구 조건은 투여 용량 60 mg, 18 mg · 연구 기간 12주 규모로 진행되었습니다.
영문 초록 원문 (PubMed Abstract) 펼쳐보기 ↓

INTRODUCTION: The WHO recommends daily oral iron supplementation for 12 weeks in women and adolescents where anaemia prevalence is greater than 40%. However, if iron deficiency is not a major cause of anaemia, then, at best, untargeted iron supplementation is a waste of resources; at worst, it could cause harm. Further, different forms of iron with varying bioavailability may present greater risks of harm. METHODS AND ANALYSIS: A 12-week three-arm, double-blind, randomised controlled supplementation trial was conducted in Cambodia to determine if there is potential harm associated with untargeted iron supplementation. We will recruit and randomise 480 non-pregnant women (ages 18-45 years) to receive one of three interventions: 60 mg elemental iron as ferrous sulfate (the standard, commonly used form), 18 mg ferrous bisglycinate (a highly bioavailable iron amino acid chelate) or placebo. We will measure ferritin concentrations (to evaluate non-inferiority between the two forms of iron), as well as markers of potential harm in blood and stool (faecal calprotectin, gut pathogen abundance and DNA damage) at baseline and 12 weeks. Mixed-effects generalised linear models will be used to assess the effect of iron on ferritin concentration and markers of potential harm at 12 weeks. ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of British Columbia Clinical Research Ethics Board (H18-02610), the Children's and Women's Health Centre of British Columbia Research Ethics Board (H18-02610) and the National Ethics Committee for Health Research in Cambodia (273-NECHR). Findings will be published in peer-reviewed journals, presented to stakeholders and policymakers globally and shared within participants' communities. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04017598). © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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