A Randomized, Double-blind, Controlled Trial in Rural Burkina Faso to Determine the Optimal Amount of Zinc to Include in a Lipid-based Nutrient Supplement (LNS). Part of the iLiNS Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,220
- 试验地点
- 1
- 主要终点
- Change in length and length-for-age Z-score
研究概览
简要总结
To assess zinc-related biochemical and functional responses among young Burkinabe children with a presumed high risk of zinc deficiency who receive micronutrient products containing different amounts of zinc, provided with or between meals.
详细描述
Young healthy children will be identified by periodic consensus in the study area. 3200 infants meeting a set of eligibility criteria will be randomly assigned to receive lipid-based nutrient supplements (LNS) with different amounts of zinc and a placebo or zinc supplement from 9 to 18 months of age. The families will receive the respective supplement at weekly intervals and the participants undergo a morbidity evaluation weekly, anthropometric evaluation at 9, 12, 15 and 18 months and laboratory analyses at enrollment and at 18 months of age. Growth outcomes will be analyzed during the two-year follow up at 24, 30, 36 and 42 months of age.
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
- 9 Months 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •9.0 to 9.9 mo of age
排除标准
- •severe anemia
- •severely malnourished
- •presence of bipedal oedema
- •severe illness
- •congenital abnormalities
- •chronic medical condition
- •known HIV infection of mother or infant
- •history of peanut allergy
- •history of anaphylaxis or serious allergic reaction to any substance
研究组 & 干预措施
LNS-Zn5
Daily intake of 20 g LNS containing 5 mg of zinc and a daily placebo supplement
干预措施: LNS-Zn5 (Dietary Supplement)
LNS-Zn10
Daily intake of 20 g LNS containing 10 mg of zinc and a daily placebo supplement
干预措施: LNS-Zn10 (Dietary Supplement)
LNS-Zn0
Daily intake of 20 g LNS containing 0 mg of zinc and a daily placebo supplement
干预措施: LNS-Zn0 (Dietary Supplement)
Suppl-Zn5
Daily intake of zinc supplement containing 5 mg of zinc and 20 g LNS containing 0 mg of zinc
干预措施: Suppl-Zn5 (Dietary Supplement)
Delayed intervention group
Standard care from age 8 to 18 months. Daily consumption of LNS from age 18 to 28 months.
结局指标
主要结局
Change in length and length-for-age Z-score
时间窗: 9 to 18 mo of age
Change in plasma zinc concentration
时间窗: 9 to 18 mo of age
Incidence of diarrhea and laboratory-confirmed malaria infection
时间窗: 9 to 18 mo of age
Change in weight and weight-for-age Z-score
时间窗: 9 to 18 mo of age
Change in body composition
时间窗: 9 to 18 mo of age
次要结局
- Incidence of acute lower respiratory infection (ALRI)(9 to 18 mo of age)
- Change in stunting, underweight, and wasting(9 to 18 mo of age)
- Change in hemoglobin, iron, vitamin A and iodine status(9 to 18 mo of age)
- Change in head circumference and mid-upper arm circumference(9 to 18 mo of age)