Complementary Food Supplements for Reducing Childhood Undernutrition

December 3, 2017 updated by: Parul Christian, Johns Hopkins Bloomberg School of Public Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5449

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Gaibandha, Bangladesh
        • The JiVitA Project, Johns Hopkins Bangladesh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infants 6 months of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No food
A control in which mothers will receive nutrition education about continued breastfeeding and adequate complementary feeding throughout the period of 6-18 months of age.
Active Comparator: Plumpy Doz
In this control arm children will receive prepackaged, lipid-based Plumpy'Doz (Nutriset, Mulaunay, France) for daily consumption as a snack.
Dietary supplement: Plumpy Doz
Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals.
Experimental: Wheat Soy Blend (WSB++)
Children will receive a WFP-developed Wheat-Soy Blend (WSB++) snack to be consumed daily.
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.
Experimental: Chickpea based complementary food supplement
Children will receive a Chickpea based complementary food supplement to be consumed daily.
Dietary supplement: Chickpea based complementary food supplement
A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals.
Experimental: Rice based complementary food supplement
Children will receive a locally developed rice based complementary food supplement.
Dietary supplement: Rice based complementary food supplement
Locally developed rice based complementary food with and added vitamins and minerals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stunting in Children at 18 mo
Time Frame: 18 months of age
Prevalence of stunting at 18 months of age.
18 months of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity
Time Frame: 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.
weekly from 6 to 18 months of age
Body Composition
Time Frame: 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
At 6, 9 and 12 months of age
Developmental Milestones
Time Frame: At 6, 12, and 18 months of age
Age-specific developmental milestones will be assessed
At 6, 12, and 18 months of age
Cognitive and Motor Function
Time Frame: At 18 months of age
Using Bayley III
At 18 months of age
Micronutrient Status
Time Frame: 18 months of age
Iron, vitamin A, zinc and other micronutrient status of children will be examined by intervention group.
18 months of age
Intestinal Function
Time Frame: 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
At 24 months of age

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Knowledge, Attitude and Practice Related to Infant and Young Child Feeding
Time Frame: At 6, 12 and 18 months of age
Maternal KAP
At 6, 12 and 18 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh
United Nations World Food Programme (WFP)
DSM Ltd

Investigators

  • Principal Investigator: Parul Christian, DrPH, Johns Hopkins Bloomberg School of Public Health
  • Study Director: Keith P West, DrPH, Johns Hopkins Bloomberg School of Public Health
  • Study Director: Alain B Labrique, PhD, Johns Hopkins Bloomberg School of Public Health
  • Study Director: Rebecca Merrill, PhD, Johns Hopkins Bloomberg School of Public Health
  • Study Director: Abu Ahmed Shamim, MS, JiVitA
  • Study Director: Hasmot Ali, MPH, JiVitA
  • Study Director: Tahmeed Ahmed, PhD, International Centre for Diarrhoeal Disease Research, Bangladesh
  • Study Director: Saskia de Pee, PhD, WFP
  • Study Director: Martin Bloem, PhD, WFP
  • Study Director: Monira Parveen, PhD, WFP
  • Study Director: Britta Schumacher, PhD, WFP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

March 9, 2012

First Submitted That Met QC Criteria

March 22, 2012

First Posted (Estimate)

March 23, 2012

Study Record Updates

Last Update Posted (Actual)

August 24, 2018

Last Update Submitted That Met QC Criteria

December 3, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00003703
  • NIFA210-38418-21732 (Other Grant/Funding Number: USDA)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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