A Randomised Controlled Trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Childhood Severe Malnutrition
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Total long chain PUFA in erythrocyte membranes at 3 months
研究概览
简要总结
The investigators will perform a randomised controlled trial of the provision of food designed for rehabilitation of malnourished children that is supplemented with n-3 fatty acids compared to usual composition. The investigators want to see whether the provision of such a food normalises the deficiencies in essential fatty acids observed in severely malnourished children faster than standard composition.
详细描述
Randomized controlled trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Severe Malnutrition.
Description of Study Design: Randomized Controlled Trial
Study Duration: 6 months (Trial); 12 months (All trial-related activities)
Description of Intervention: Provision of ready to use food (RUTF) enriched with flax seed oil, with or without fish oil, compared to conventional-composition RUTF. Interventional product will be given until nutritional recovery to a maximum of 12 weeks.
Design: Flax-enriched or standard RUTF allocation is randomised and double blind. Fish oil allocation is randomised within those receiving flax-enriched RUTF and is open label.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 months to 5 years old
- •Provision of informed consent
- •Severe malnutrition (one or more of mid-upper arm circumference <11.5cm, weight for height z score <-3, or nutritional oedema)
- •Stabilised and eligible to receive RUTF according to national guidelines
排除标准
- •Known HIV disease, tuberculosis or other chronic infection*
- •Known allergy or hypersensitivity to any of the product ingredients
- •Chronic infections such as HIV and tuberculosis and their treatments are likely to cause alterations in lipid metabolism that may confound interpretation of this pilot trial. national guidelines recommend offering provider-initiated testing for HIV for all severely malnourished children, and referral for comprehensive care in the case of a positive test.
结局指标
主要结局
Total long chain PUFA in erythrocyte membranes at 3 months
时间窗: 3 months
Total long chain PUFA in erythrocyte membranes at 3 months
次要结局
- Change in weight for height z score between baseline and 3 months(3 months)
- Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months(3 months)
- Total long chain PUFA in plasma at 3 months(3 months)
- Change in mid upper arm circumference between baseline and 3 months(3 months)
- Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months(3 months)
- Total long chain PUFA in CD3 cell membranes at 3 months(3 months)
- Ratio of n-6:n-3 PUFA in plasma at 3 months(3 months)