Phase 3
N=5,449
Complementary Food Supplements for Reducing Childhood Undernutrition
Stunting · Wasting
Bottom Line
View on ClinicalTrials.gov: NCT01562379 ↗Enrolled (actual)
5,449
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Stunting in Children at 18 mo — 559; 542; 341; 300 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Wheat Soy Blend (WSB++) (Dietary_supplement); Chickpea based complementary food supplement (Dietary_supplement); Rice based complementary food supplement (Dietary_supplement); Plumpy Doz (Dietary_supplement)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stunting in Children at 18 mo |
559; 542; 341; 300; 330 | — |
| SECONDARY Morbidity |
— | — |
| SECONDARY Body Composition |
— | — |
| SECONDARY Developmental Milestones |
— | — |
| SECONDARY Cognitive and Motor Function |
— | — |
| SECONDARY Micronutrient Status |
— | — |
| SECONDARY Intestinal Function |
— | — |
Summary
The purpose of this study is to test the impact on child growth of three specially formulated complementary food supplements vs. Plumpy'Doz, a previously tested, commercially available complementary food, and vs. a control group that receives no food. All groups will receive nutrition education related to infant and young child feeding. This will be a cluster-randomised trial in children 6-18 months old in rural Rangpur and Gaibandha in Bangladesh.
Eligibility Criteria
Inclusion Criteria
- Infants 6 months of age
Data sourced from ClinicalTrials.gov (NCT01562379). 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.