A Hospital based prospective open randomized controlled trial to compare the efficacy of Soya based Medical Nutrition Therapy (S-MNT) with Peanut based Medical nutritional Therapy (P-MNT) in children with severe acute malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 2) To assess the rate of weight gain.
研究概览
简要总结
All children who satisfy the criteriafor Severe Acute Malnutrition (SAM) will be enrolled in this project aftercounseling and consent of their parents. Children with SAM having complicationwill be admitted at LTMGH, Sion. They will be stabilized with F75 and F100alongwith emergency care and then enrolled in the project. Uncomplicated SAMchildren will be enrolled at NRRTC on OPD bases. This includeimmune-compromised (irrespective of ART) as well as children infected withtuberculosis (TB) after ruling out significant underlying disease. They will betreated atleast for period of 14days (maximum 3months) alongwith the mother orcaretaker of the child. All the details would be entered in the predesigned andpretested proforma.
1. Nutritional History: Detailed nutritionalassessments will be done at baseline, 2 weekly thereafter for 6 weeks and thenmonthly for 6 months from the baseline. At eachevaluation the history of the child’s eating habits,food allergies and use of nutritional supplements, history ofnausea, vomiting, abdominal pain, abdominal distention, and diarrhea orconstipation would be assessed.
2. 2. Anthropometricmeasurements: Weight, height/ length and Mid upper armcircumference (MUAC) would be done at baseline, 2 weekly thereafter for 6 weeksand then monthly for 6 months from the baseline. Weight would be measured tothe nearest 100g on a regularly calibrated electronic scale with the childstanding barefoot/sleeping and undressed. Height would be measured to thenearest 1 mm using standard measuring techniques; the mean of two readingswould be calculated for each child. For measurement of MUAC, with the forearmheld perpendicular to the upper arm, a paper measuring tape would be used torecord the circumference at the mid-point between the olecranon process of theulna and the acromial process of the scapula. The mean of 3 measurements wasused for analysis.
- Z-scores would becalculated using published normal reference data.Wt/Ht, MUACwill be plotted on WHO growth charts for evaluation & monitoring ofNutritional status and progress of recovery at least for a period of 4 - 12months after 6wks of RUTF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 60.00 Month(s)（—）
- 性别
- All
入选标准
- •Children between 6 months to 60 months referred to OPD &/or admitted with SAM as per one of the 3 criteria (WHO) W/H < -3 SD or MUAC < 11.5 cm or Bilateral Pedal edema.
排除标准
- •1.Children with chronic illnesses 2.Inability to take orally 3.Children already on any nutritional supplements.
结局指标
主要结局
2) To assess the rate of weight gain.
时间窗: 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 6 month
3) To assess proportion of children achieving weight gain(target weight)
时间窗: 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 6 month
1) To assess the efficacy of Soya based MNT in children with SAM without significant chronic medical disease in community.
时间窗: 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 6 month
4) To assess the outcome at the end of 8 weeks.
时间窗: 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 6 month
次要结局
- To compare the efficacy of Soya based MNT in children with Peanut based MNT.(2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 6 month)