Effect of Pearl millet (Bajra) supplementation VS Ready to use supplementary food on the growth of children with moderate acute malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To compare the recovery rate in 2-5 years old children with moderate acute malnutrition receiving Pearl millet (Bajra)-based diet supplementation with those receiving RUSF
研究概览
简要总结
The study aims to evaluate the effect of pearl millet supplementation on the growth of 2–5-year-old children with moderate acute malnutrition (MAM). It primarily compares the recovery rate, measured by the change in weight-for-height Z-score, between children receiving pearl millet-based supplementation and those receiving ready-to-use supplementary food (RUSF) over three months. Secondary objectives include comparing changes in hemoglobin levels, recovery time, relapse rates within six months, and caregiver satisfaction. Conducted at UCMS & GTB Hospital in Delhi, this open-label randomized controlled trial involves 120 children, divided into two groups. Anthropometric measurements and hemoglobin levels will be assessed at baseline and after three months, with follow-ups to monitor progress and compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Children (aged
- •5 years) with moderate acute malnutrition according to the WHO criteria.
排除标准
- •Children with known chronic systemic disease, congenital malformations, chromosomal anomalies, inborn errors of metabolism, already on / history of iron supplementation in preceding 4 weeks, children with mothers having understanding issues due to language barrier • Children with mothers not having primary education.
结局指标
主要结局
To compare the recovery rate in 2-5 years old children with moderate acute malnutrition receiving Pearl millet (Bajra)-based diet supplementation with those receiving RUSF
时间窗: At baseline, 3 months
次要结局
- (1) Change in hemoglobin level (2) Average time required for recovery((3) Proportion of children relapsed at 6 months from enrolment)
研究者
Dr Ishani Jha
University College of Medical Sciences