Complementary Food Supplements for Reducing Childhood Undernutrition

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
International Centre for Diarrhoeal Disease Research, Bangladesh
United Nations World Food Programme (WFP)
DSM Ltd
Information provided by (Responsible Party):
Parul Christian, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01562379
First received: March 9, 2012
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Stunting
Wasting
Dietary Supplement: Wheat Soy Blend (WSB++)
Dietary Supplement: Chickpea based complementary food supplement
Dietary Supplement: Rice based complementary food supplement
Dietary Supplement: Plumpy Doz
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of Complementary Food Supplements For Reducing Childhood Undernutrition: The JiVitA-4 Study

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Stunting and wasting [ Time Frame: Change from 6 months to 18 months of age ] [ Designated as safety issue: No ]
    Change in length-for-age and weight-for-length Z scores and the prevalence of stunting and wasting at 18 months of age.


Secondary Outcome Measures:
  • Morbidity [ Time Frame: weekly from 6 to 18 months of age ] [ Designated as safety issue: No ]
    weekly morbidity will be assessed for a year and episodes of diarrhea, dysentery ALRI, and fever will be recorded.

  • Body composition [ Time Frame: At 6, 9 and 12 months of age ] [ Designated as safety issue: No ]
    Bioelectrical impedance analysis will be used to look at body composition changes from baseline until 18 months of age

  • Developmental milestones [ Time Frame: At 6, 12, and 18 months of age ] [ Designated as safety issue: No ]
    Age-specific developmental milestones will be assessed

  • Cognitive and motor function [ Time Frame: At 18 months of age ] [ Designated as safety issue: No ]
    Using Bayley III


Estimated Enrollment: 5320
Study Start Date: September 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   6 Months to 8 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants 6 months of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562379

Locations
Bangladesh
The JiVitA Project, Johns Hopkins Bangladesh
Gaibandha, Bangladesh
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
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: Rolf Klemm, DrPH Johns Hopkins Bloomberg School of Public Health
Study Director: Alain B Labrique, PhD Johns Hopkins Bloomberg School of Public Health
Study Director: Kerry J Schulze, PhD Johns Hopkins Bloomberg School of Public Health
Study Director: Sucheta Mehra, MS 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
  More Information

No publications provided

Responsible Party: Parul Christian, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01562379     History of Changes
Other Study ID Numbers: 00003703, NIFA210-38418-21732
Study First Received: March 9, 2012
Last Updated: September 24, 2013
Health Authority: United States: Institutional Review Board
Bangladesh: Ethical Review Committee

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
complementary food supplements
stunting
wasting
growth
Bangladesh
infant feeding

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on April 16, 2014