Complementary Food Supplements for Reducing Childhood Undernutrition

NCT01562379 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 5449

Last updated 2018-08-24

Study results available
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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.

Conditions

  • Stunting
  • Wasting

Interventions

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.

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER
  • United Nations World Food Programme (WFP)

    collaborator OTHER
  • DSM Ltd

    collaborator INDUSTRY
  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Parul Christian, DrPH · Johns Hopkins Bloomberg School of Public Health

  • Keith P West, DrPH · Johns Hopkins Bloomberg School of Public Health

  • Rolf Klemm, DrPH · Johns Hopkins Bloomberg School of Public Health

  • Alain B Labrique, PhD · Johns Hopkins Bloomberg School of Public Health

  • Kerry J Schulze, PhD · Johns Hopkins Bloomberg School of Public Health

  • Sucheta Mehra, MS · Johns Hopkins Bloomberg School of Public Health

  • Rebecca Merrill, PhD · Johns Hopkins Bloomberg School of Public Health

  • Abu Ahmed Shamim, MS · JiVitA

  • Hasmot Ali, MPH · JiVitA

  • Tahmeed Ahmed, PhD · International Centre for Diarrhoeal Disease Research, Bangladesh

  • Saskia de Pee, PhD · WFP

  • Martin Bloem, PhD · WFP

  • Monira Parveen, PhD · WFP

  • Britta Schumacher, PhD · WFP

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
8 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-05-31
Completion
2014-11-30

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01562379 on ClinicalTrials.gov