Complementary Food Supplements for Reducing Childhood Undernutrition
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|ClinicalTrials.gov Identifier: NCT01562379|
Recruitment Status : Completed
First Posted : March 23, 2012
Results First Posted : August 24, 2018
Last Update Posted : August 24, 2018
|Condition or disease||Intervention/treatment||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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5449 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Complementary Food Supplements For Reducing Childhood Undernutrition: The JiVitA-4 Study|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||November 2014|
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.
- Stunting in Children at 18 mo [ Time Frame: 18 months of age ]Prevalence of stunting at 18 months of age.
- Morbidity [ Time Frame: weekly from 6 to 18 months of age ]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 ]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 ]Age-specific developmental milestones will be assessed
- Cognitive and Motor Function [ Time Frame: At 18 months of age ]Using Bayley III
- Micronutrient Status [ Time Frame: 18 months of age ]Iron, vitamin A, zinc and other micronutrient status of children will be examined by intervention group.
- Intestinal Function [ Time Frame: At 24 months of age ]Intestinal function using L:M and other biomarkers will be assessed by intervention group and its association with child growth
- Maternal Knowledge, Attitude and Practice Related to Infant and Young Child Feeding [ Time Frame: At 6, 12 and 18 months of age ]Maternal KAP
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562379
|The JiVitA Project, Johns Hopkins Bangladesh|
|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|