The Effectiveness of Ready to Use Therapeutic Food (RUTF) in Catch up Growth in Children After an Episode of P. Falciparum Malaria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- weight gain
研究概览
简要总结
The primary objective of this study is to determine to what extent provision with RUTF will promote catch up growth in children following an acute uncomplicated episode of P. falciparum malaria.
详细描述
Anorexia due to infection might lead to weight loss. In many settings total recovery is problematic what might result in a permanent lower weight. A short period high quality food supplementation could improve weight gain after an infection.
Children aged 6-59 months presenting with malaria caused by P. falciparum who are provided with a RUTF supplement (Plumpynut®) of 500 kcal/day for 2 weeks will show significantly better catch up growth compared to a similar patient group not provided with RUTF (at 2 weeks and 4 weeks post-intervention).
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
- None
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
- •Age 6 to 59 months, and
- •Positive rapid diagnostic test (Paracheck®) and
- •Thick smear showing infection with P. falciparum and
- •Informed consent from parents or guardian aged at least 18 years.
排除标准
- •Children who are exclusively breast fed or
- •Children who are severely malnourished (MUAC <110 mm and/or bilateral oedema, or WHO weight-for-Height criteria <3 Z-scores) or
- •Presence of general danger signs or signs of severe malaria as defined by the WHO criteria, or
- •Known history of allergy to malaria drugs, or
- •Having a sibling enrolled in the study.
研究组 & 干预措施
control
no supplement given
RUTF
RUTF supplement (Plumpynut®) of 500 kcal/day for 2 weeks
干预措施: RUTF (Plumpynut®) (Dietary Supplement)
结局指标
主要结局
weight gain
时间窗: 14 days
次要结局
- weight gain(28 days)
研究者
Saskia van der Kam
Ir
Medecins Sans Frontieres, Netherlands