Phase 3
Completed N=5,449
Complementary Food Supplements for Reducing Childhood Undernutrition
Source: ClinicalTrials.gov NCT01562379 ↗Enrolled (actual)
5,449
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Stunting in Children at 18 mo — 559; 542; 341; 300 Participants
◆ Published Evidence
Established
62citations · ~7 / year
Biomarkers of Environmental Enteric Dysfunction Among Children in Rural Bangladesh.
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.
Linked Publications (5)
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Biomarkers of Environmental Enteric Dysfunction Among Children in Rural Bangladesh.
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Complementary Food Supplements Increase Dietary Nutrient Adequacy and Do Not Replace Home Food Consumption in Children 6-18 Months Old in a Randomized Controlled Trial in Rural Bangladesh.
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Supplementation with Fortified Lipid-Based and Blended Complementary Foods has Variable Impact on Body Composition Among Rural Bangladeshi Children: A Cluster-Randomized Controlled Trial.
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Novel Method for Estimating Nutrient Intakes Using a Semistructured 24-Hour Diet Recall for Infants and Young Children in Rural Bangladesh.
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Complementary Food Supplements Fill Energy and Protein Gaps among Children with Dietary Inadequacy in a Complementary Feeding Trial in Rural Bangladesh.
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 |
— | — |
Eligibility Criteria
Inclusion Criteria
- Infants 6 months of age
Data sourced from ClinicalTrials.gov (NCT01562379) and the linked publication. 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. Informational only — not medical advice.