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.
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ile Ife、尼日利亚
- Obafemi Owalowo University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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)
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的: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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实验性的: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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实验性的: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Iron isotopic composition of the blood at the end of each intervention period
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Iron isotopic composition of the blood
大体时间: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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合作者和调查者
赞助
调查人员
- 首席研究员:Funke Olumakaiye, PhD、Obafemi Awolowo University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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