Iron Absorption From a Nutritional Iron Supplement
Conventional oral iron supplements often cause gastrointestinal side effects and are limited by poor bioavailability, leaving unabsorbed iron to reach the colon. Hydrocolloid-based hydrogel matrix formulations designed for gradual iron release present a promising approach to improve iron absorption. This study evaluates fractional iron absorption (FIA) from three low-dose hydrogel formulations containing ferrous fumarate compared with ferrous fumarate without a hydrogel matrix. Test products will be administered with water, with and without a standardized breakfast. All formulations will be intrinsically labelled with stable iron isotopes ( 57Fe or 54Fe), and FIA will be determined 14 days after administration based on erythrocyte iron incorporation. In this randomized, within-subject corssover study conducted in non-anemic, iron-depleted women, each participant will receive all test conditions and serve as her own control.
연구 개요
상태
개입 / 치료
- 건강 보조 식품: Iron-Enriched Hydrogel Supplement (A with breakfast)
- 건강 보조 식품: Iron-Enriched Hydrogel Supplement (B with breakfast)
- 건강 보조 식품: Iron-Enriched Hydrogel Supplement (A without breakfast)
- 건강 보조 식품: Iron-Enriched Hydrogel Supplement (B without breakfast)
- 건강 보조 식품: Iron-Enriched Hydrogel Supplement (C with breakfast)
- 건강 보조 식품: Control (FeFum, with breakfast)
- 건강 보조 식품: Control (FeFum, without breakfast)
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Camarena
- 전화번호: +41446328393
- 이메일: seline.camarena@pharma.ethz.ch
연구 장소
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-
Canton of Zurich
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Zurich, Canton of Zurich, 스위스, 8006
- 모병
- ETH Zürich, Laboratory of Clinical Biopharmacy
-
연락하다:
- Camarena
- 전화번호: +41446328393
- 이메일: seline.camarena@pharma.ethz.ch
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Female aged 18 to 45 years
- Plasma ferritin <30 µg/L
- Body mass index (BMI) 18.5 kg/m2 - 24.9 kg/m2.
- Body weight <65 kg.
- Signed informed consent
- Sufficient command of English (mother tongue or B2 level)
Exclusion Criteria:
- Anemia, defined as hemoglobin (Hb) <120 g/L (<12.0 g/dL).
- Elevated systemic inflammatory markers (C-reactive protein >5.0 mg/L).
- Chronic digestive, renal and/or metabolic diseases
- Chronic medications (except for contraceptives)
- Use of vitamin, mineral, or pre-/Pprobiotic supplements in the 2 weeks before or during the study
- Blood transfusion, blood donation or significant blood loss (>400ml) over the past 4 months
- Difficulty with blood withdrawal
- Pregnancy (tested in serum/urine) or intention to become pregnant during the course of the study
- Lactation
- Previous participation in a study using stable isotopes or participation in any clinical study within the last 30 days
- Participants who cannot be expected to comply with the study protocol (e.g. not available on certain study appointments)
- Inability to understand the information sheet and the informed consent form due to cognitive or language reasons
- Smoking (>1 cigarette/week)
- Vegan diet (the standardized breakfast contains plain whole milk yogurt and butter)
Special exclusion criteria for participants in the MRI imaging sub-study (n=9):
- Presence of a heart pacemaker, neurostimulator, or any other active implanted electronic device.
- Use of a hearing aid that cannot be safely removed for the MRI examination.
- Use of removable dentures that cannot be safely removed for the MRI examination.
- History of surgery on the head or heart involving implanted material that is not confirmed MRI-safe.
- Presence of metallic objects in the body (e.g. implants, magnets, metal splinters, gunshot fragments, tattoos, piercings, or surgical clips) that are not confirmed MRI-safe.
- History of metal splinter injury (e.g. ocular foreign body) or occupational exposure associated with increased risk of retained metal fragments.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: FeHydro-A with breakfast (Condition 1)
FeHydro-A with sodium ascorbate, consumed with a standardized breakfast |
FeHydro-A (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + Standardized Breakfast
다른 이름들:
|
|
실험적: FeHydro-B with breakfast (Condition 2)
FeHydro-B without sodium ascorbate, consumed with a standardized breakfast |
FeHydro-B (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + Standardized Breakfast
다른 이름들:
|
|
실험적: FeHydro-A without breakfast (Condition 3)
FeHydro-A with sodium ascorbate, consumed without breakfast |
FeHydro-A (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + 300 mL Water |
|
실험적: FeHydro-B without breakfast (Condition 4)
FeHydro-B without sodium ascorbate, consumed without breakfast |
FeHydro-B (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + 300 mL Water |
|
실험적: FeHydro-C with breakfast (Condition 5)
FeHydro-C with sodium ascorbate and gum arabic, consumed with a standardized breakfast |
FeHydro-C (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + Standardized Breakfast |
|
활성 비교기: Control with breakfast (Condition 6)
Control ferrous fumarate, consumed with a standardized breakfast |
Control (20 mg elemental iron as ferrous fumarate without hydrogel matrix, in gelatin capsule; labeled with 57Fe or 54Fe) + Standardized Breakfast |
|
활성 비교기: Control without breakfast (Condition 7)
Control ferrous fumarate, consumed without breakfast |
Control (20 mg elemental iron as ferrous fumarate without hydrogel matrix, in gelatin capsule; labeled with 57Fe or 54Fe) + 300 mL Water |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fractional Iron Absorption
기간: 14 days after administration of each labelled test condition
|
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in red blood cells |
14 days after administration of each labelled test condition
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRONH
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual participant data (IPD) will not be made publicly available to protect participant privacy and maintain confidentiality regarding proprietary formulation data. De-identified, aggregated study results and primary outcome data will be published in peer-reviewed scientific journals and made available via public study registries upon completion of the trial.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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