Evaluation of Iron Absorption From Ferric Ammonium Phosphate and Ferric Pyrophosphate From an Instant Milk Drink in Young Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Determination of iron absorption from FAP and from ferric pyrophosphate relative to Ferrous sulfate
研究概览
简要总结
The primary objective was:
- to compare iron absorption in apparently healthy children aged 3-6y from an instant full cream milk drink fortified with ferric pyrophosphate or ferric ammonium phosphate relative to ferrous sulfate as the reference fortificant.
- To compare iron absorption from ferric pyrophosphate to ferric ammonium phosphate from the milk drink
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •3-6 years old (inclusive)
- •Normal BMI for age (WHO standard)
- •Apparently healthy, no metabolic or gastrointestinal disorder
- •Non-anemic (WHO cut-off for respective age
- •No medication or vitamin/mineral supplements will be consumed during the study
- •Intake of Vitamin/mineral supplements 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
- •Having obtained his/her parents or his/her legal representative's informed consent
排除标准
- •With known gastrointestinal or metabolic disorder or experiencing significant blood losses over the past 6 months
- •Possible to have medication during the study
- •Currently participating or having participated another clinical trial during the past 3 months prior the beginning of this study
- •Subject who cannot be expected to comply with treatment
结局指标
主要结局
Determination of iron absorption from FAP and from ferric pyrophosphate relative to Ferrous sulfate
时间窗: 14 days post isotope consumption
It is based on calculated amount of 58Fe and 57Fe appearing in the blood. For that the shift of the iron isotope ratios in the blood samples collected 14 days after the last consumption of the last test drink are measured. The calculation of circulating iron is based on blood volume and hemoglobin concentration. For calculations of fractional absorption, 90% incorporation of the absorbed iron into red blood cells is assumed. The relative iron absorption from FAP and from ferric pyrophosphate relative to ferrous sulfate is then calculated as follows: Relative bioavailability of a salt (RBV %) = ( Fe absorption from an iron salt/ Fe absorption from ferrous sulfate)∗ 100. The comparison of the iron absorption from ferric pyrophosphate to that from ferric ammonium phosphate will be made by statistical analysis of data measured and calculated as described above.
次要结局
未报告次要终点