Community-based Intervention Trial to Compare the Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children in Burkina Faso
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,680
- 试验地点
- 1
- 主要终点
- Incidence of diarrhea and laboratory-confirmed malaria
研究概览
简要总结
Zinc supplementation can either be provided in a lower daily dose to prevent zinc deficiency or in a higher dose for 10-14 days as part of the treatment of diarrhea. It is important to determine how best to integrate programs designed either to prevent zinc deficiency or to treat diarrhea.
The overall objective of this project is to determine the most effective approach to prevent zinc deficiency and treat diarrhea, such that a single approach could provide the maximal beneficial impact on the health and nutritional status of young children and greatest simplicity of implementation.
详细描述
This is a single-center cluster- and household-randomized, partially masked, community-based efficacy trial of zinc supplementation. The study sample consists of 5 study groups in one region, with 34 clusters randomly assigned to 3 types of intervention communities.
Communities will be randomly assigned to 1) early intervention communities, 2) later intervention communities, 3) non-intervention communities. Within each intervention cluster, children will be randomly assigned to the intervention group at the household level. Children aged 6-27 months at enrollment will be eligible. The study duration is 12 months.
The investigators will assess the relative impact of daily preventive zinc supplementation (7 mg zinc/d for one year), intermittent preventive supplementation (10 mg zinc/d for 10 days every three months for one year), and zinc treatment during episodes of diarrhea (20 mg zinc/d for 10 days beginning with each episode of diarrhea during one year). Outcomes that will be assessed include the incidence and duration of all episodes of diarrhea, the incidence of malaria, physical growth, and (in a sub-group) biochemical indicators of zinc, iron and vitamin A status.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 27 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6-27 months of age
- •Plan to remain in study area for 1 year
排除标准
- •Evidence of congenital abnormalities and chronic infection
- •Severe anemia and severe acute malnutrition
- •Consumption of micronutrient supplementation including zinc
研究组 & 干预措施
Daily preventive Zn; placebo treatment
7 mg zinc per day for 12 months and placebo supplement during diarrhea episode
干预措施: Daily preventive Zn; placebo treatment (Dietary Supplement)
Therapeutic Zn; daily placebo
20 mg of zinc for 10 days during episodes of diarrhea and daily placebo supplement
干预措施: Therapeutic Zn; daily placebo (Dietary Supplement)
Intermittent Zn; placebo treatment
10 mg zinc for 10 days every 3 months, daily placebo during 80 days of 3 months period and placebo during diarrhea episode
干预措施: Intermittent Zn; placebo treatment (Dietary Supplement)
Surveillance control group
Surveillance control group will be randomly assigned to intervention groups every 3 months
干预措施: Surveillance control group (Other)
Non-intervention
Standard care provided by health system
结局指标
主要结局
Incidence of diarrhea and laboratory-confirmed malaria
时间窗: 12 months
Change in plasma zinc concentration
时间窗: 12 months
Change in weight and weight-for-age
时间窗: 12 months
Change in length and length-for-age Z-score
时间窗: 12 months
次要结局
- Change in hemoglobin and iron status(12 months)
- Incidence of stunting, underweight, and wasting(12 months)