Complementary Food Supplements for Reducing Childhood Undernutrition
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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 |
- 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.
- 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.
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|
|
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 |
Inclusion Criteria:
- Infants 6 months of age
Contacts and Locations| Contact: Parul Christian, DrPH | 410-955-1188 | pchristi@jhsph.edu |
| Contact: Sucheta Mehra, MSc, MS | 410-614-2531 | smehra@jhsph.edu |
| Bangladesh | |
| The JiVitA Project, Johns Hopkins Bangladesh | Recruiting |
| Gaibandha, Bangladesh | |
| Contact: Ahmed A Shamim, MSc MPH +8801713163485 shamim.jivita@gmail.com | |
| Contact: Hasmot Ali, MBBS, MPH +8801713163461 hasmot.jivita@gmail.com | |
| 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, 2012 |
| 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 May 22, 2013