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临床试验/NCT01695148
NCT01695148已完成3 期

Efficacy of β-carotene Biofortified Maize in Improving Vitamin A Status and Reducing the Prevalence of Vitamin A Deficiency Among Children in Rural Zambia

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 1,228 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
1,228
试验地点
1
主要终点
Decreased Prevalence of Vitamin A deficiency

研究概览

简要总结

The purpose of this cluster-randomized trial is to examine whether daily consumption of β-carotene biofortified maize flour can reduce the prevalence of vitamin A deficiency and improve the vitamin A status and among 4-8 year old children in rural Zambia.

详细描述

Vitamin A deficiency is a major public health problem in Zambia, affecting approximately 40% of young children. We aim to conduct a cluster-randomised controlled trial in the Mkushi region of rural Zambia to test whether feeding children two daily meals containing β-carotene biofortified maize flour compared to regular white maize flour-based meals for six months can reduce the prevalence of vitamin A deficiency and improve the vitamin A status among 4-8 year old children. Five hundred children in each arm will receive 2 meals a day, 6 days a week for 6 months, after which changes in serum retinol concentrations will be compared. An additional arm of 250 children, enrolled from randomly sampled clusters, will not receive the maize flour intervention but concurrently followed in order to evaluate overall effects of the maize flour feeding scheme on measures of household food security.

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
None

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children 4-8 years of age

排除标准

  • 未提供

结局指标

主要结局

Decreased Prevalence of Vitamin A deficiency

时间窗: After 6 months of feeding

The investigators hypothesize a difference of 10% or more in the prevalence of vitamin A deficiency (i.e., serum retinol \< 0.7 μmol/l) among children consuming biofortified versus white maize flour-based meals, assuming a baseline prevalence of 40%.

Increased Serum Retinol Concentration

时间窗: After 6 months of feeding

The investigators hypothesize a difference of 2.5 μg/dL or more in serum retinol among children receiving biofortified versus white maize flour-based meals. Serum retinol measures will be collected at baseline and at the end of 6 months and assessed by a High Performance Liquid Chromatography assay.

次要结局

  • Improved Dark Adaptation(After 6 months of Feeding)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Keith P. West

Professor

Johns Hopkins Bloomberg School of Public Health

研究点 (1)

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