N/A
N=2,259
Whey Permeate Study
Malnutrition
Bottom Line
View on ClinicalTrials.gov: NCT01790048 ↗Enrolled (actual)
2,259
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Recovery From Moderate Acute Malnutrition (MAM) — 960; 874 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Whey permeate RUSF (Dietary_supplement); Soy Protein RUSF (Dietary_supplement)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recovery From Moderate Acute Malnutrition (MAM) |
960; 874 | — |
| SECONDARY Weight |
2.95; 2.79 | — |
| SECONDARY Height |
0.30; 0.29 | — |
| SECONDARY Mid-Upper-Arm Circumference (MUAC) Gain |
0.26; 0.22 | — |
| SECONDARY Time to Graduation |
29.3; 30.4 | — |
| SECONDARY Adverse Events |
0; 0 | — |
Summary
This is a prospective, randomized, double-blinded, controlled clinical effectiveness trial of two supplementary foods in the treatment of MAM.
Specific Aim 1: Test the effectiveness of two supplementary foods, whey RUSF and soy RUSF, in the treatment of MAM in 6-59 month old children in a 12-week home-based supplementary feeding program.
Hypothesis: The proportion of children who recover receiving either soy or whey RUSF will differ by no more than three percent.
Eligibility Criteria
Inclusion Criteria
- Children with MAM defined as mid-upper-arm circumference, MUAC, ≤ 12.5 cm and > 11.5 cm without bipedal edema.
Exclusion Criteria
- Children simultaneously involved in another research trial or supplemental feeding program
- Children with developmentally delayed
- Children with a chronic debilitating illness such as cerebral palsy (not including HIV or TB)
- Children with a history of peanut or milk allergy
- Children will also be excluded if they had received therapy for acute malnutrition within one month prior to presentation.
Data sourced from ClinicalTrials.gov (NCT01790048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.