Assessment of the Bioavailability of Iron in Iron Fortified Bouillon Cubes in Healthy Nigerian Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Iron isotopic composition of the blood at the end of each intervention period
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Low stabilizer level
Meals prepared with iron fortified cube with low stabilizer level
干预措施: Meals prepared with iron fortified cube with Low stabilizer level (Other)
Medium stabilizer level
Meals prepared with iron fortified cube with medium stabilizer level
干预措施: Meals prepared with iron fortified cube with Medium stabilizer level (Other)
High stabilizer level
Meals prepared with iron fortified cube with high stabilizer level
干预措施: Meals prepared with iron fortified cube with High stabilizer level (Other)
结局指标
主要结局
Iron isotopic composition of the blood at the end of each intervention period
时间窗: 16 days
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.
次要结局
- Iron isotopic composition of the blood(1, 22, 43 and 64 days)