NCT01423162已完成4 期
Iron Bioavailability Study Of Fortified Oat Drink
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Percent Iron Absorption
研究概览
简要总结
This study will follow a double blinded randomized controlled study design to enroll 20 apparently healthy 6 year old children. The children will be fed with two different nutrient fortified oat drinks labeled with stable isotopes of iron (Fe-57 or Fe-58 as NaFeEDTA). Fourteen days after consumption of meals on Day 2, blood will be drawn from the children for stable isotope measurements and iron absorption will be calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6 year old children (inclusive)
- •Normal BMI for age (WHO standard: 15.3-15.5 kg)
- •Apparently healthy, no metabolic or gastrointestinal disorder; non-anemic (Hemoglobin values not less than 11.5 mg/dL -WHO cut-off for respective age)
- •No medication or vitamin/mineral supplement will be consumed during the study; intake of vitamin/mineral supplement will be discontinued 2 weeks before the start of the study
- •Parents demonstrate an understanding of the given information and ability to comply with the study procedure
- •Obtained parental or legal representative's informed consent
排除标准
- •Known gastrointestinal or metabolic disorder or experiencing blood losses over the past 6 months;
- •Children taking medication
- •Children who are anemic (Hemoglobin values less than 11.5 mg/dL - WHO cut-off value for this age)
- •Currently participating or having participated in another clinical trial during the past 3 months prior to the beginning of the study
结局指标
主要结局
Percent Iron Absorption
时间窗: 14 days after administration
Percentage of iron available for absorption from fortified oat drink with and without added vitamin C
次要结局
未报告次要终点
研究者
研究点 (1)
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