Complementary Food Supplements for Reducing Childhood Undernutrition
NCT01562379 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 5449
Last updated 2018-08-24
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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