NCT01562379

Complementary Food Supplements for Reducing Childhood Undernutrition

Evaluation of Complementary Food Supplements For Reducing Childhood Undernutrition: The JiVitA-4 Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 5,449 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 6 Months – 8 Months
• Healthy volunteers: Accepted

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.

Conditions

• Stunting
• Wasting

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Wheat Soy Blend (WSB++)	A wheat formulation containing protein from milk solids and soybeans, essential fats and sugar to provide optimal caloric density, and added vitamins and minerals.
DIETARY_SUPPLEMENT	Chickpea based complementary food supplement	A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals.
DIETARY_SUPPLEMENT	Rice based complementary food supplement	Locally developed rice based complementary food with and added vitamins and minerals.
DIETARY_SUPPLEMENT	Plumpy Doz	Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals.

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-05-01
• Completion: 2014-11-01
• First posted: 2012-03-23
• Last updated: 2018-08-24
• Results posted: 2018-08-24

Locations

1 site across 1 country: Bangladesh