Ready to Use Supplementary Food in Moderate Childhood Malnutrition

Study Overview
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Brief Summary
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Since 2001, Ready to Use Therapeutic Foods (RUTF) are widely used to treat severe malnutrition. Their efficacy and effectiveness were proven in community therapeutic care programs. Recently, the question rose if RUTF would be more effective than enriched flours to treat moderate malnutrition. The purpose of this study is to compare the effectiveness of Ready to Use Food Supplementary-plumpy® and Premix Corn Soy Blend with oil in term of cure rate, weight gain, duration of treatment, morbidity and mortality in the treatment of moderate acute malnutrition. Compare the longer term effect on nutritional status and morbidity (relapse?).

Official Title
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Effectiveness of a Ready-to-Use-Supplementary-Food for the Treatment of Moderate Childhood Malnutrition

Conditions
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Moderate Acute Malnutrition

Intervention / Treatment
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* Dietary Supplement: Ready to Use Supplementary Food
* Dietary Supplement: Premix CSB-oil treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all children aged 6 months to 5 years admitted to SFC outpatient care during the study period WHM between 70-79% (1977 NCHS/WHO standard) without edema approval from the caretaker Exclusion Criteria: presence of the following signs: bilateral edema, MUAC<110 mm , WHM< 70%(criteria for severe malnutrition), and medical complications necessitating hospitalisation refusal to participate from caretaker

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ready to Use Supplementary Food<br>Ready to Use Supplementary Food treatment | Dietary Supplement: Ready to Use Supplementary Food<br>* Children received two Supplementary-plumpy® packages per day (184g) providing 1000 Kcal, 26g (10.4%) protein, 68g (61.2%) fat, and 100% of micronutrient requirements based on the Daily Recommended Nutrient Intake.<br>* Other names: Supplementary-plumpy®;|
| Active Comparator: Premix<br>Premix Corn Soy Blend-oil treatment | Dietary Supplement: Premix CSB-oil treatment<br>* Children received 2 kg of premix per week (226g CSB, 37g oil, and 23g sugar / day) providing 1277 Kcal, 40.7g protein (12.7%), 50.6g (35.7%) fat, and 100% of micronutrient according to the DRNI guidelines<br>* Other names: Fortified Blended Flours;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery | proportion of children who recovered, defined as WHM> 85% for two consecutive weeks | 112 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average weight gain | in g per kg of weight per day | 112 days | 
| Duration of treatment | average length of stay in days. | 112 days | 
| Morbidity | number of morbidity episodes during the treatment and six months thereafter | 11 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate, Wasting, Malnutrition, Ready to Use Food, Fortified Blended Flour