Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Infant vitamin A stores
研究概览
简要总结
The purpose of this randomized control trial is to test the impact of provitamin A carotenoid biofortified maize meal consumption on maternal and infant vitamin A status.
详细描述
Vitamin A deficiency remains a major public health problem in low and middle income countries. Approximately 50% of Zambian children are thought to be affected. This randomized control trial will test the efficacy of provitamin A carotenoid biofortified maize meal consumption as a strategy to improve vitamin A status among lactating Zambian mothers and their infants. The investigators will enroll up to 255 mother/infant pairs to a three-month study, during which they will receive one of the following three interventions: 1) conventional white maize, 2) provitamin A carotenoid biofortified orange maize, or 3) preformed vitamin A fortified white maize.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton birth
- •No birth defects
- •Free from chronic health conditions
- •Infant received 100,000 IU vitamin A at 6 months of age
- •Currently breastfeeding
- •Not pregnant at 9 months post partum
- •Hemoglobin > 8.0 g/dL for women and > 7.0 g/dL for infants
排除标准
- •Multiple birth
- •Birth defects
- •Any chronic health condition requiring regular medical visits
- •Infant did not receive vitamin A capsule at 6 months of age
- •No longer breastfeeding
- •Hemoglobin ≤ 8.0 g/dL for women or ≤ 7.0 g/dL for infants
研究组 & 干预措施
White maize
Conventional maize flour
干预措施: Conventional white maize (Dietary Supplement)
Biofortified maize
Provitamin A carotenoid biofortified maize flour
干预措施: Provitamin A carotenoid biofortified maize (Dietary Supplement)
Fortified maize
Retinyl palmitate fortified maize flour
干预措施: Preformed vitamin A fortified maize (Dietary Supplement)
结局指标
主要结局
Infant vitamin A stores
时间窗: 90 days
Total body vitamin A stores of infants measured by retinol isotope dilution
次要结局
- Maternal breast milk retinol(90 days)
- Maternal plasma retinol(90 days)
- Maternal dark adaptation(90 days)