Determination of Changes in Total Body Stores of Vitamin A in Response to Orange Maize Consumption by Zambian Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 主要终点
- Vitamin A status changes
研究概览
简要总结
Determination of liver stores of vitamin A will be determined before and after consumption of high pro-vitamin A orange maize, compared to low provitamin A white maize.
详细描述
This study will determine the change in total body stores of vitamin A in response to feeding orange maize for 90 days. This will be compared to two other groups of children that are fed white maize, one of which will get a vitamin A supplement at the estimated average requirement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 57 Months 至 88 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 57-88 months at the time of initiation of the study
- •Children living in the locality defined by the study and not enrolled in school.
- •Consent from parent/guardian.
排除标准
- •Severely malnourished children (weight for age or height z-scores <-3 standard deviations below the WHO growth reference standards)
- •Children found to be below 57 months and still holding an under five card or above 88 months at the time of initiation of the study or enrolled in school, based on verification of birth dates at screening
- •Children whose families plan to leave the study area before completion of the study
- •Consent not obtained from parent/guardian
- •Children suffering from diarrhea at the time of initiation of the study or with high fever, based on the report of symptoms by the parent/guardian
- •Children with severe anemia (Hb <7.0 g/dL) as determined at the baseline blood draw.
研究组 & 干预措施
Orange maize
Children were fed orange maize and the intervention name was "orange"
干预措施: Orange maize feeding (Other)
Blue vitamin A group
Received vitamin A in the form of retinyl palmitate in oil at the estimated average requirment.
干预措施: Vitamin A supplement (Other)
White
Received oil only at the same volume as the vitamin A group
干预措施: Oil only (Other)
结局指标
主要结局
Vitamin A status changes
时间窗: After the intervention, which is approximately 3 months.
Vitamin A status is measured before and after the intervention.
次要结局
未报告次要终点