NCT01751009已完成不适用
A Randomised Controlled Home-based Trial of the Effects of Fortified Complementary Foods on Vitamin A Status and Body Pool Size in Ghanaian Infants.
Kintampo Health Research Centre, Ghana1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2010年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Vitamin A status after 5 months supplementation
研究概览
简要总结
This study tried to prove that children given food supplements containing vitamin A would have better liver vitamin A stores than children given food supplements without vitamin A over a 5 month period.
详细描述
The study wanted to assess the effect of fortification of home based complementary foods on vitamin A status in Ghanaian children who receive food supplements known as Sprinkles. The study assessed the vitamin A status and body pool size in children using a test known as the modified relative dose response test (MRDR) tests and stable 13C2 retinol as a tracer, among those who receive Sprinkles with or without vitamin A through home fortification of complementary foods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent of mother of eligible children aged 6-12 months.
- •Willingness to remain in the study area for entire duration of the study.
- •Willingness to agree to feed the child with supplied micronutrient supplements for duration of study.
- •The child should have started taking complementary foods in addition to breast milk.
- •Child's haemoglobin level of at least 70 g/L.
排除标准
- •Child's haemoglobin level less than 70 g/L.
- •Unable to give informed consent
结局指标
主要结局
Vitamin A status after 5 months supplementation
时间窗: 5 months
次要结局
- acceptability of home based fortified vitamin A supplements(5 months)
研究者
研究点 (1)
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