- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02815449
Assessment of the Bioavailability of Iron in Iron Fortified Bouillon Cubes in Healthy Nigerian Women
The prevalence of iron deficiency anemia is a wide spread problem in Africa and iron fortification can be an effective strategy to decrease this.
In the current study adding different levels of a stabilizer to iron fortified cubes and it's effect on iron bioavailability from these cubes will be studied in the context of a Nigerian meal in women.
24 Female subjects with low serum ferritin levels will be included in the study. The study will last 64 days and subjects will be asked to consume a breakfast and lunch prepared with a bouillon cube with isotope labeled iron during 3 periods of 5 consecutive days. The absorption of iron will be evaluated after every period and compared between the cubes.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Ile Ife, 나이지리아
- Obafemi Owalowo University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthy female Nigerian subjects;
- Age > 18 and <40 years at screening;
- Body weight <65 kg;
- Apparently healthy: no medical conditions which might affect study measurements (judged by study physician);
- With iron deficiency judged by a serum ferritin concentration of <15µg/L;
- Reported intense sporting activities ≤ 10h/w;
- Reported alcohol consumption ≤ 14 units/w;
- Willing and able to participate in the study;
- Having given a written informed consent.
Exclusion Criteria:
- Being an employee of Unilever or the Department of Family, Nutrition and Consumer Science of the Obafemi Alowolo University;
- Blood donation or significant blood loss over the past 6 months;
- Being severely anemic (hemoglobin < 8.0 g/dL)
- Reported use of any medically- or self-prescribed diet;
- Use of vitamin or mineral supplements and unwillingness to discontinue their use one week prior the study and during the study;
- Smoking or consuming tobacco in any form, and/or was smoking or consuming tobacco in any form for 6 months preceding the study and/or will be smoking or consuming tobacco in any form, during the study;
- Is pregnant or will be planning pregnancy during the study period;
- Is lactating or has been lactating in the 6 weeks before pre-study investigation and/or during the study period;
- Known gastrointestinal (including helminth infection) or metabolic disorders;
- Participation in another clinical trial during the last 30 days prior to the beginning of the study;
- Symptomatic malaria (no blood smear analyses on malaria required)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Low stabilizer level
Meals prepared with iron fortified cube with low stabilizer level
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Meals prepared with iron fortified cube with Low stabilizer level
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실험적: Medium stabilizer level
Meals prepared with iron fortified cube with medium stabilizer level
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Meals prepared with iron fortified cube with Medium stabilizer level
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실험적: High stabilizer level
Meals prepared with iron fortified cube with high stabilizer level
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Meals prepared with iron fortified cube with High stabilizer level
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Iron isotopic composition of the blood at the end of each intervention period
기간: 16 days
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The amount of iron isotopic label in the blood will be related to the low, medium and high stabilizer level in the cubes to determine whether a dose-response relationship exists.
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16 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Iron isotopic composition of the blood
기간: 1, 22, 43 and 64 days
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The amount of iron isotopic label in the blood at the end of each administration period plus 14 day incorporation time will be used to calculate the absolute Iron absorption for each stabilizer level
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1, 22, 43 and 64 days
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Funke Olumakaiye, PhD, Obafemi Awolowo University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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