Iron Bioavailability From Fortified Dairy Product in Healthy Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline in the isotopic ratio of iron in blood at week 2
研究概览
简要总结
Determination of fractional iron absorption from dairy product fortified with 2 labelled iron compounds
详细描述
This single center trial will be double-blind, controlled randomized with a crossover trial. One group (n=10) will start the study with the consumption of a Fe-54 salt fortified dairy product, while the other group will start the study with the consumption of Fe-57 salt fortified dairy product. The day after, in a cross over design, subjects will be administered the alternative test product. A blood sampling will be performed 14 days after the last stable isotope administration to allow the measurement of Fe stable isotope ratios and the calculation of Fe absorption. The duration of the trial will be 16 days in total.
The total sample size is 20 enrolled subjects. Patients will be healthy females aged 18-40 years old
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- •Women aged 18-40 years old,
- •Healthy, based on the medical screening visit including a blood formula and biochemistry,
- •Normal BMI for age (18.5-25.0),
- •Weight less than 65 kg,
- •Having obtained informed consent prior trial entry.
排除标准
- •Anemia or polycythemia respectively evidenced,
- •Significant blood losses over the past 6 months,
- •Plasma ferritin out of 8-50 ug/L range.
- •Any infectious and inflammatory disease in the past four weeks,
- •Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease,
- •Known food allergy,
- •Pregnancy (anamnesis) and/or lactation,
- •History of cancer within the past year,
- •Significant weight loss during the last 3 months (5% and more),
- •medication or supplement which may impact red cells count, Hb or Ht
- •Fe supplementation or perfusion in the last three months,
- •Smokers (>5 cigarettes),
- •Have a high alcohol consumption (more than 2 drinks/day),
- •Consumption of illicit drugs anamnesis only,
- •Subject having a hierarchical link with the Investigator or co-investigators,
- •Subject who cannot be expected to comply with treatment or study procedure,
- •participating or having participated in another clinical trial during the past month prior to the beginning of this study.
结局指标
主要结局
Change from baseline in the isotopic ratio of iron in blood at week 2
时间窗: 14 days after the last stable isotope administration
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes
次要结局
- Measurement of plasma ferritin as biomarker of Fe status(On the 1st day of the stable isotope administration)