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临床试验/NCT01147198
NCT01147198已完成不适用

Effectiveness of a Ready-to-Use-Supplementary-Food for the Treatment of Moderate Childhood Malnutrition

Medecins Sans Frontieres, Netherlands1 个研究点 分布在 1 个国家目标入组 570 人开始时间: 2007年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
570
试验地点
1
主要终点
Recovery

研究概览

简要总结

Since 2001, Ready to Use Therapeutic Foods (RUTF) are widely used to treat severe malnutrition. Their efficacy and effectiveness were proven in community therapeutic care programs. Recently, the question rose if RUTF would be more effective than enriched flours to treat moderate malnutrition.

The purpose of this study is to compare the effectiveness of Ready to Use Food Supplementary-plumpy® and Premix Corn Soy Blend with oil in term of cure rate, weight gain, duration of treatment, morbidity and mortality in the treatment of moderate acute malnutrition.

Compare the longer term effect on nutritional status and morbidity (relapse?).

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
None

入排标准

年龄范围
6 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • all children aged 6 months to 5 years admitted to SFC outpatient care during the study period
  • WHM between 70-79% (1977 NCHS/WHO standard) without edema
  • approval from the caretaker

排除标准

  • presence of the following signs: bilateral edema, MUAC<110 mm , WHM< 70%(criteria for severe malnutrition), and medical complications necessitating hospitalisation
  • refusal to participate from caretaker

结局指标

主要结局

Recovery

时间窗: 112 days

proportion of children who recovered, defined as WHM\> 85% for two consecutive weeks

次要结局

  • average weight gain(112 days)
  • Duration of treatment(112 days)
  • Morbidity(11 months)

研究者

发起方
Medecins Sans Frontieres, Netherlands
申办方类型
Other

研究点 (1)

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