Effectiveness Comparison of Three Supplementary Foods in the Treatment of Moderate Acute Malnutrition

Study Overview
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Brief Summary
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The purpose of this study is to compare the recovery rates of moderately malnourished Malawian children treated with either milk-enriched corn/soy blend, soy/peanut fortified spread or a commercially produced ready-to-use therapy food.

Official Title
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Comparison of a Novel Fortified Blended Flour to Ready-to-use Supplemental Foods for the Treatment of Moderate Acute Malnutrition in Rural Malawian Children: a Randomized, Investigator-blinded, Clinical Effectiveness Trial

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: Soy/peanut fortified spread
* Dietary Supplement: Milk fortified corn/soy blend
* Dietary Supplement: Supplementary Plumpy®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: WHZ <-2 but >-3 without bilateral pedal edema Reside within 7 kilometers of study site. Exclusion Criteria: Not permanent resident in vicinity of study site. Severe chronic illness such as cerebral palsy. History of peanut allergy or anaphylaxis resulting from any food. Receiving other supplementary food or participating in other research.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Soy/peanut fortified spread<br> | Dietary Supplement: Soy/peanut fortified spread<br>* 75kcal/kg/day<br>|
| Experimental: Milk fortified corn/soy blend<br> | Dietary Supplement: Milk fortified corn/soy blend<br>* 75 kcal/kg/day<br>|
| Active Comparator: Supplementary Plumpy®<br> | Dietary Supplement: Supplementary Plumpy®<br>* 75 kcal/kg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Nutritional Recovery | Recovery is defined by weight for height Z (WHZ) score of -2 or greater using enrollment length. WHZ will be computed using standard WHO growth standards: http://www.who.int/childgrowth/standards/en/ | 12 weeks or upon completion of recovery | 
| Number of Patients With Absence of Bilateral Pedal Pitting Edema |  | 12 weeks or recovery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Weight Gain | This rate will be measured up to the 2nd followup visit (4 weeks) or up to the 1st followup visit (2 weeks) if the child recovered after only 2 weeks | 4 weeks | 
| Number of Patients With Adverse Outcomes | This includes children with allergic or other adverse reactions that could be attributed to their assigned intervention food. | 12 months | 
| Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment |  | 2 weeks | 
| Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) | Children who were successfully treated for MAM in the primary portion of the study were followed prospectively with scheduled follow-up visits for 12 months to evaluate whether they remained well-nourished, defined as mid-upper arm circumference (MUAC) >= 12.5 cm or weight-for-height Z-score >= -2 throughout the duration of follow-up. | 12 months | 
| Rates of Gain in Mid-upper Arm Circumference, and Length | These rates will be measured up to the 2nd followup visit (4 weeks) or up to the 1st followup visit (2 weeks) if the child recovered after only 2 weeks | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malnutrition, Supplemental Food, CSB++, Supplementary Plumpy