Evaluation of Complementary Food Supplements For Reducing Childhood Undernutrition: The JiVitA-4 Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Stunting
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Enrollment
- 5449
- Locations
- 1
- Primary Endpoint
- Stunting in Children at 18 mo
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Detailed Description
Childhood stunting and growth faltering is highly prevalent in South Asia. Among other strategies, adequate complementary feeding practices and provision of complementary foods that are appropriate and fill the nutrient gap by providing macro and micronutrients essential for growth are important means to reduce the global burden of undernutrition and related morbidity and mortality. We propose to evaluate the impact of three complementary food supplement products that are fortified with micronutrients in a rural, remote setting in Bangladesh, where high rates of childhood undernutrition persist on child growth, health, and development. The three foods being tested are an enhanced wheat-soy blend (WSB++) developed by WFP, and locally developed chickpea-based and a rice-based complementary food supplements. We will assess the impact of feeding these daily against the non-fed controls, hypothesizing that the children fed these foods show increased length for age Z scores (LAZ) and weight for length age Z scores (WLZ) of \>0.21 and decreased prevalence of stunting and wasting by \>10%. We expect that the impact of the three foods will be equivalent/ non-inferior to that of Plumpy'Doz.
Investigators
Parul Christian
Professor
Johns Hopkins Bloomberg School of Public Health
Eligibility Criteria
Inclusion Criteria
- •Infants 6 months of age
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Stunting in Children at 18 mo
Time Frame: 18 months of age
Prevalence of stunting at 18 months of age.
Secondary Outcomes
- Morbidity(weekly from 6 to 18 months of age)
- Intestinal Function(At 24 months of age)
- Developmental Milestones(At 6, 12, and 18 months of age)
- Micronutrient Status(18 months of age)
- Cognitive and Motor Function(At 18 months of age)
- Body Composition(At 6, 9 and 12 months of age)