N/A
N=2,712
Effectiveness Comparison of Three Supplementary Foods in the Treatment of Moderate Acute Malnutrition
Malnutrition
Bottom Line
View on ClinicalTrials.gov: NCT00998517 ↗Enrolled (actual)
2,712
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Number of Participants With Nutritional Recovery — 763; 795; 807 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Soy/peanut fortified spread (Dietary_supplement); Milk fortified corn/soy blend (Dietary_supplement); Supplementary Plumpy® (Dietary_supplement)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Nutritional Recovery |
763; 795; 807 | — |
| PRIMARY Number of Patients With Absence of Bilateral Pedal Pitting Edema |
850; 871; 879 | — |
| SECONDARY Rate of Weight Gain |
3.1; 3.4; 3.6 | — |
| SECONDARY Number of Patients With Adverse Outcomes |
0; 0; 0 | — |
| SECONDARY Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment |
271; 303; 309; 89; 127; 124 | — |
| SECONDARY Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM) |
402; 382; 446; 110; 117; 107 | — |
| SECONDARY Rates of Gain in Mid-upper Arm Circumference, and Length |
0.13; 0.13; 0.21; 0.13; 0.13; 0.15 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- WHZ -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.
Data sourced from ClinicalTrials.gov (NCT00998517). 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.