CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,449 enrolled
Drug / intervention
Wheat Soy Blend (WSB++) +3 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01562379
NCT01562379Phase 3Completed

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

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Mar 23, 2012·Updated Aug 24, 2018

In Brief

A Phase 3 clinical trial evaluating Wheat Soy Blend (WSB++), Chickpea based complementary food supplement, and 2 other interventions for Stunting and Wasting. Completed, enrolled 5,449 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStunting, Wasting
CountriesBangladesh

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 23, 2012
Enrollment StartSep 1, 2012
Primary CompletionMay 1, 2014
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.3 years ago

Interventions

Wheat Soy Blend (WSB++)dietary

A wheat formulation containing protein from milk solids and soybeans, essential fats and sugar to provide optimal caloric density, and added vitamins and minerals.

Chickpea based complementary food supplementdietary

A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals.

Rice based complementary food supplementdietary

Locally developed rice based complementary food with and added vitamins and minerals.

Plumpy Dozdietary

Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals.