Comparison of a Novel Fortified Blended Flour to Ready-to-use Supplemental Foods for the Treatment of Moderate Acute Malnutrition in Rural Malawian Children: a Randomized, Investigator-blinded, Clinical Effectiveness Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,712
- 试验地点
- 1
- 主要终点
- Number of Patients With Absence of Bilateral Pedal Pitting Edema
研究概览
简要总结
The purpose of this study is to compare the recovery rates of moderately malnourished Malawian children treated with either milk-enriched corn/soy blend, soy/peanut fortified spread or a commercially produced ready-to-use therapy food.
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 (Investigator)
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
- •WHZ <-2 but >-3 without bilateral pedal edema
- •Reside within 7 kilometers of study site.
排除标准
- •Not permanent resident in vicinity of study site.
- •Severe chronic illness such as cerebral palsy.
- •History of peanut allergy or anaphylaxis resulting from any food.
- •Receiving other supplementary food or participating in other research.
研究组 & 干预措施
Supplementary Plumpy®
干预措施: Supplementary Plumpy® (Dietary Supplement)
Soy/peanut fortified spread
干预措施: Soy/peanut fortified spread (Dietary Supplement)
Milk fortified corn/soy blend
干预措施: Milk fortified corn/soy blend (Dietary Supplement)
结局指标
主要结局
Number of Patients With Absence of Bilateral Pedal Pitting Edema
时间窗: 12 weeks or recovery
Number of Participants With Nutritional Recovery
时间窗: 12 weeks or upon completion of recovery
Recovery is defined by weight for height Z (WHZ) score of -2 or greater using enrollment length. WHZ will be computed using standard WHO growth standards: http://www.who.int/childgrowth/standards/en/
次要结局
- Rate of Weight Gain(4 weeks)
- Rates of Gain in Mid-upper Arm Circumference, and Length(4 weeks)
- Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM)(12 months)
- Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment(2 weeks)
- Number of Patients With Adverse Outcomes(12 months)