Effectiveness of Nutritional Supplementation (RUTF and Multi Micronutrient) in Preventing Malnutrition in Children 6-59 Months With Infection (Malaria, Pneumonia, Diarrhoea), a Randomized Controlled Trial in Nigeria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,213
- 试验地点
- 1
- 主要终点
- "negative nutritional outcome" of a child
研究概览
简要总结
The purpose of this study is to determine whether 14 days nutritional supplementation with Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection will prevent malnutrition and reduce the frequency of morbidity.
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.
A complete high quality food will be tested, but also micronutrients alone as there is no information on what children with an infection exactly need as a supplement.
Children aged 6-59 months presenting with diarrhoea, malaria or lower respiratory tract infection (LRTI) are provided for 2 weeks with
- RUTF supplement (Plumpynut®) of 500 kcal/day
- Multi-micronutrient powder (MNP)
- Placebo to MNP
The followup period is 6 months. Anthropometric indicators and morbidity are assessed monthly. Participants are invited to attend the study clinic if any signs of disease are noticed.
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
- Double (Investigator, 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
- •6 to 59 months of age
- •Not malnourished or moderately acutely malnourished children
- •Diagnosis of malaria and/or diarrhoea and/or LRTI
- •Intending to remain in area for the duration of the 6 month follow-up
- •Living within approximately 60 minutes walking distance from the clinic
- •Informed consent from a guardian*
排除标准
- •Child is exclusively breastfeeding
- •Child is severely malnourished
- •Presence of 'General Danger Signs'
- •Presence of severe disease (including severe malaria, severe LRTI, severe diarrhoea)
- •Needing hospitalisation for any reason
- •Known history of allergy to the nutritional supplementation
- •Having a sibling enrolled in the study*
结局指标
主要结局
"negative nutritional outcome" of a child
时间窗: 6 months follow-up
The incidence of a negative nutritional outcome will be defined in two different ways according to the baseline nutritional status. i) for children with no malnourishment at time of entry into study, "negative nutritional outcome" is defined as progression to moderate or severe malnourishment ii) for children with moderate malnourishment at time of entry into study, "negative nutritional outcome" is defined as loss of ³10% of baseline weight or progression to severe malnourishment, whichever is reached first.
次要结局
- Number of new events of a study disease(6 months)
研究者
Saskia van der Kam
Ir
Medecins Sans Frontieres, Netherlands