Complementary Food Supplements for Reducing Childhood Undernutrition

Phase 2

Completed

• Conditions: Stunting; Wasting

• Registration Number: NCT01562379
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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.

Study Timeline

• Study First Submitted: 2012-03-09
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-23
• Study Start: 2012-09
• Primary Completion: 2014-05
• Study Completion: 2014-11
• Status Verified: 2017-12
• Results First Submitted: 2017-12-03
• Results First Submitted QC: 2017-12-03
• Last Update Submitted: 2017-12-03
• Results First Posted: 2018-08-24
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5449

Inclusion Criteria

• Infants 6 months of age

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stunting in Children at 18 mo	18 months of age	Prevalence of stunting at 18 months of age.

Secondary Outcome Measures

Name	Time	Method
Morbidity	weekly from 6 to 18 months of age	weekly morbidity will be assessed for a year and episodes of diarrhea, dysentery ALRI, and fever will be recorded.
Intestinal Function	At 24 months of age	Intestinal function using L:M and other biomarkers will be assessed by intervention group and its association with child growth
Cognitive and Motor Function	At 18 months of age	Using Bayley III
Body Composition	At 6, 9 and 12 months of age	Bioelectrical impedance analysis will be used to look at body composition changes from baseline until 18 months of age
Developmental Milestones	At 6, 12, and 18 months of age	Age-specific developmental milestones will be assessed
Micronutrient Status	18 months of age	Iron, vitamin A, zinc and other micronutrient status of children will be examined by intervention group.

Trial Locations

Locations (1)

The JiVitA Project, Johns Hopkins Bangladesh; 🇧🇩 Gaibandha, Bangladesh

The JiVitA Project, Johns Hopkins Bangladesh

🇧🇩Gaibandha, Bangladesh