Evaluation of the Impact of Vitamin A and Zinc Supplementation on Malarial Morbidity in Ghana
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- incidence of clinical malaria attacks
研究概览
简要总结
The purpose of this study was to determine whether young children receiving Vitamin A and Zinc supplements will have a lower incidence of symptomatic malaria than similar children receiving vitamin A supplements alone.
详细描述
The aim of our study was to determine the impact of the combination of vitamin A and zinc supplements on malaria morbidity in young children. The primary objective was to determine the effect of vitamin A alone vs. vitamin A and zinc supplements on the incidence of clinical malaria. The specific objectives were to determine the effect of vitamin A alone vs. vitamin A and zinc supplements on changes in anthropometric measurements specifically weight and length/height and to assess the effect of the study interventions on the incidence of anemia, diarrhea and pneumonia. It also assessed the tolerability of the supplements and determined the change in zinc status by measuring plasma zinc concentration using atomic absorption spectrometry before and at the end of the intervention. The study also determined the change in vitamin A status as assessed by the modified relative dose response (MRDR) test during and at the end of the intervention.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 - 24 months
- •Child's guardian is willing to provide informed consent
- •Child's family plans to remain resident in the study areas during the study period
排除标准
- •Clinical evidence of vitamin A deficiency
- •Severe acute malnutrition
- •Severe illness
- •Child aged <6 months or >24 months
- •Receipt of vitamin A supplement within the last three months
结局指标
主要结局
incidence of clinical malaria attacks
时间窗: 6 months
次要结局
- changes in weight and height/length(baseline and 6 months)
- changes in vitamin A and zinc nutritional status within and between the groups(baseline and 6 months)
- change in prevalence of anemia(baseline and 6 months)
- the incidence of diarrhea and pneumonia(1 time per week up to 6 months)