EFFICACY AND SAFETY OF F100 PREPARED BY RECIPE METHOD FOR WEIGHT GAIN IN SEVERELY ACUTE MALNOURISHED CHILDREN
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 4
- 主要终点
- Mean weight gain (g/kg/day) during rehabilitation
研究概览
简要总结
This open-label randomized controlled trial evaluates the efficacy and safety of multiple formulations of the F-100 therapeutic feed during the rehabilitation phase among children aged 6-59 months with SAM, in comparison to standard WHO F-100. The primary outcome is daily weight gain (g/kg/day) over 10 days; secondary outcomes include MUAC improvement, gastrointestinal tolerance (vomiting/diarrhea), duration to recovery, and renal safety markers (serum urea, creatinine, serum sodium, urine-specific gravity).
详细描述
This open-label randomized controlled trial evaluates the efficacy and safety of multiple formulations of the F-100 therapeutic feed during the rehabilitation phase among children aged 6-59 months with SAM, in comparison to standard WHO F-100. The study includes four arms: the WHO commercial F-100 powder (control), recipe-based locally prepared F-100 (Arm A), diluted F-100 (Arm B), and an alternative locally prepared high-energy RUTF-like blend (Arm C). The primary outcome is daily weight gain (g/kg/day) over 10 days; secondary outcomes include MUAC improvement, gastrointestinal tolerance (vomiting/diarrhea), duration to recovery, and renal safety markers (serum urea, creatinine, serum sodium, urine-specific gravity).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-59 months
- •Diagnosed with SAM
- •Have completed stabilization and entering rehabilitation phase per WHO CMAM guidelines
排除标准
- •Secondary malnutrition (e.g. tuberculosis, HIV)
- •Chronic systemic diseases
- •Congenital anomalies
- •Terminal illness
结局指标
主要结局
Mean weight gain (g/kg/day) during rehabilitation
时间窗: From randomization to after starting treatment 10 days
Mean weight gain (g/kg/day) during 10 days of rehabilitation
次要结局
- Safety profile(From randomization to after starting treatment 10 days)
- Acceptability and Palatability by Hedonic scale scores for taste and acceptability of F-100(day 1)
- Change in serum albumin levels from baseline to day 10(base line and day 10)
- MUAC(From randomization to after starting treatment 10 days)
研究者
Dr. Saadia Khan
Principal Investigator
Children's Hospital and Institute of Child Health, Multan