Effect of Daily Consumption of β-carotene Biofortified Maize on Milk Retinol Concentration in Lactating Zambian Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Breast milk retinol concentration
研究概览
简要总结
The purpose of the study is to determine whether daily consumption of beta-carotene biofortified maize will increase breast milk retinol concentration in lactating Zambian women.
详细描述
Lactating women were randomly assigned to one of three intervention groups to receive 6d/wk for 3 wk either 1) provitamin A biofortified orange maize and a corn oil capsule, 2) white maize and a vitamin A capsule, or 3) white maize and a corn oil capsule. The 'orange maize' and 'vitamin A' groups received ~600 ug RAE/d as provitamin A biofortified maize or retinyl palmitate, respectively. The 'white maize' group was a negative control group that did not receive any supplemental vitamin A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy lactating women 18-35 years of age
- •who are breastfeeding a single infant, 4-12 mo of age.
排除标准
- •Pregnancy,
- •Chronic disease,
- •Hb concentration <90 g/L,
- •Signs or symptoms of vitamin A deficiency
结局指标
主要结局
Breast milk retinol concentration
时间窗: After 3 weeks of intervention
Breast milk retinol concentration will be measured before and after 3 wk of consumption of orange maize (6 d/wk)
次要结局
- Breastmilk beta-carotene concentration(After 3 wk of intervention)