Improved Polyunsaturated Ready-to-use Therapeutic Food for Improved Neurocognitive Outcomes in Severe Acute Malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,897
- 试验地点
- 1
- 主要终点
- Neurocognitive outcome
研究概览
简要总结
An appropriate balance of omega-6 and omega-3 fatty acids is important for support of neurocognitive development in healthy infants and toddlers. In young children recovering from severe acute malnutrition (SAM), excess omega-6 intake depletes omega-3 fatty acid status. This research will evaluate how novel ready-to-use therapeutic foods (RUTF) with balanced fatty acids improve the metabolic and neurocognitive effects in young children in Malawi recovering from SAM, yielding new knowledge that also has implications for development of well-nourished children.
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 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6-59 months
- •An acceptable appetite defined by the ability to consume 30 grams RUTF within 20 minutes
- •Mid Upper Arm Circumference <11.5 cm, weight-for-height z-score < -3, or bilateral pitting edema on the dorsum of the feet
排除标准
- •Participation in any other ongoing study or supplementary feeding program
- •Children with a chronic medical condition, including cerebral palsy, static encephalopathy, congenital heart disease, gastrointestinal disease, or peanut allergy
研究组 & 干预措施
DHA-supplemented HO-RUTF (D-HO-RUTF)
The treatment provided to children randomized to this arm of the study mirrors that provided by HO-RUTF with that addition of supplemental DHA at a level higher than attainable with optimal precursors.
干预措施: Amoxicillin (Drug)
Conventional RUTF (S-RUTF)
This is the control group for the study, which will receive the international standard of care therapeutic food. S-RUTF is made with conventional peanuts, which are inherently high in omega-6 linoleic acid.
干预措施: Amoxicillin (Drug)
Conventional RUTF (S-RUTF)
This is the control group for the study, which will receive the international standard of care therapeutic food. S-RUTF is made with conventional peanuts, which are inherently high in omega-6 linoleic acid.
干预措施: S-RUTF (Dietary Supplement)
High oleic RUTF (HO-RUTF)
The treatment provided to children randomized to this arm of the study includes nutritional content comparable to S-RUTF with the exception of a low lineoleic acid/high oleic acid ratio formulated with high oleic content peanuts.
干预措施: Amoxicillin (Drug)
High oleic RUTF (HO-RUTF)
The treatment provided to children randomized to this arm of the study includes nutritional content comparable to S-RUTF with the exception of a low lineoleic acid/high oleic acid ratio formulated with high oleic content peanuts.
干预措施: HO-RUTF (Dietary Supplement)
DHA-supplemented HO-RUTF (D-HO-RUTF)
The treatment provided to children randomized to this arm of the study mirrors that provided by HO-RUTF with that addition of supplemental DHA at a level higher than attainable with optimal precursors.
干预措施: D-HO-RUTF (Dietary Supplement)
结局指标
主要结局
Neurocognitive outcome
时间窗: Time Frame: within 4 weeks after nutritional outcome
Defined by Willatts intention score adapted for field training, 3 problems to be tested. The scale is ordinal in nature, with higher values indicated better scores * The scale title is "Intention Score" * Problem 1 is scored 0 - 4 * Problem 2 is scored 0 - 4 * Problem 3 is scored 0 - 8
次要结局
- Attentional orienting speed(4-7 months after nutritional after nutritional outcome)
- Acceptance of RUTF(Fortnightly follow up visits up to 12 weeks following enrollment)
- Adverse Events(Fortnightly follow up visits up to 12 weeks following enrollment)
- Nutritional recovery(Up to 12 weeks following enrollment)