Comparison of Treatment of Severe Acute Malnutrition in Children 6 to 59 Months Old With Standard Ready To Use Therapeutic Food and Newly Formulated Lipid Optimized Ready To Use Therapeutic Food an Individual Randomized Double Blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Number of Participants Recovered from Severe Acute Malnutrition as Assessed by WHO Anthro v3.1
研究概览
简要总结
The goal of this randomized clinical trial is to learn if a newly formulated Lipid-Optimized Ready-to-Use Therapeutic Food (LO-RUTF) can treat severe acute malnutrition in children aged 6 to 59 months. The main questions it aims to answer are:
- Does LO-RUTF impact physical recovery from severe acute malnutrition in participants?
- Does LO-RUTF impact neurocognitive performance after 8 and 12 weeks of treatment?
Researchers will compare LO-RUTF to standard RUTF see if our energy-dense food compares to standard issue RUTF in terms of promoting recovery from severe acute malnutrition.
Participants will
- Take a one-week ration of LO-RUTF or standard RUTF based on the participant's weight
- Return every week for checkups, tests and to receive the next ration of assigned RUTF if eligible
- Be assessed for neurocognitive function through Malawi Developmental Assessment Tool (MDAT) at three time points (before treatment, 4 weeks, 12 weeks)
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
- Double (Participant, 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
- •Children aged 6-59 months with severe acute malnutrition, i.e., MUAC <11.5 cm, and/or weight-for-height/length z-score < -3, and/or with bilateral pitting edema, with an appetite to completely consume a 30 g test feeding, and without medical complications presenting at selected rural therapeutic feeding health facilities
排除标准
- •Children that are simultaneously involved in another research trial or supplemental feeding program, are developmentally delayed, have vision or hearing deficits, or have a history of milk or peanut allergy.
- •Chronic diseases such as malabsorption, chronic kidney disease, inflammatory bowel disease, congenital heart disease, endocrine disorders (e.g., hypothyroidism, growth hormone deficiencies), recurrent infections (e.g., pneumonia, cough, fever, pharyngitis), chronic respiratory diseases (e.g., asthma, lung diseases), congenital or acquired immunodeficiency, and neurological disorders
研究组 & 干预措施
LO-RUTF
Participants in the LO-RUTF arm will receive approximately 190 kcal/kg/day of Lipid-Optimized Ready to Use Therapeutic Food (RUTF). This RUTF is locally produced and contains maize, milk powder, rice flour, soymeal, sugar, whey isolate, palm oil, flaxseed oil, coconut oil, premix and an emulsifier.
干预措施: Lipid-Optimized Ready to Use Therapeutic Food (RUTF) (Dietary Supplement)
RUTF
Participants in the RUTF arm will receive approximately 190 kcal/kg/day of Ready to Use Therapeutic Food (RUTF). This RUTF produced by UNICEF contains peanut paste, sugar, non-fat dried milk, vegetable oil, a premix containing concentrated minerals and vitamins, and an emulsifier.
干预措施: Ready to Use Therapeutic Food (RUTF) (Dietary Supplement)
结局指标
主要结局
Number of Participants Recovered from Severe Acute Malnutrition as Assessed by WHO Anthro v3.1
时间窗: From enrollment to the end of treatment at 8 weeks
The primary outcome is recovery from SAM, defined as: mid-upper arm circumference ≥ 11.5cm (for two consecutive weekly visits), and/or weight-for-height/length z-score \> -3 SD, and/or no bilateral pitting edema (for two consecutive weekly visits).
次要结局
- Change in MDAT Scores after 8 and 12 weeks of treatment(Baseline and after 8 and 12 weeks of treatment)
- Time to Recovery from Severe Acute Malnutrition(From enrollment to the end of the study period at 12 weeks)
- Time to Recovery from Moderate Acute Malnutrition(From enrollment to the end of the study period at 12 weeks)
- Proportion of Participants with Relapse of Moderate Acute Malnutrition(From enrollment to the end of the study period at 12 weeks)
- Proportion of Participants with Relapse of Severe Acute Malnutrition(From enrollment to the end of the study period at 12 weeks)
- Number of Participants with Non-Responder Status(From enrollment to the end of the study period at 12 weeks)
- Incidence of Adverse Events(From enrollment to the end of the study period at 12 weeks)
- Incidence of Hypercalcemia, Hypervitaminosis D, or excessive DHA concentrations(From baseline to the end of treatment at 8 weeks)
研究者
Ahmed Moutwakil
Co-Investigator
University of California, Los Angeles