Complementary Food Supplements for Reducing Childhood Undernutrition

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stunting, Wasting

Intervention / Treatment
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* Dietary Supplement: Wheat Soy Blend (WSB++)
* Dietary Supplement: Chickpea based complementary food supplement
* Dietary Supplement: Rice based complementary food supplement
* Dietary Supplement: Plumpy Doz


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants 6 months of age

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 8 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No food<br>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<br>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<br>* Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals.<br>|
| Experimental: Wheat Soy Blend (WSB++)<br>Children will receive a WFP-developed Wheat-Soy Blend (WSB++) snack to be consumed daily. | Dietary Supplement: Wheat Soy Blend (WSB++)<br>* A wheat formulation containing protein from milk solids and soybeans, essential fats and sugar to provide optimal caloric density, and added vitamins and minerals.<br>|
| Experimental: Chickpea based complementary food supplement<br>Children will receive a Chickpea based complementary food supplement to be consumed daily. | Dietary Supplement: Chickpea based complementary food supplement<br>* A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals.<br>|
| Experimental: Rice based complementary food supplement<br>Children will receive a locally developed rice based complementary food supplement. | Dietary Supplement: Rice based complementary food supplement<br>* Locally developed rice based complementary food with and added vitamins and minerals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stunting in Children at 18 mo | Prevalence of stunting at 18 months of age. | 18 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | weekly morbidity will be assessed for a year and episodes of diarrhea, dysentery ALRI, and fever will be recorded. | weekly from 6 to 18 months of age | 
| Body Composition | Bioelectrical impedance analysis will be used to look at body composition changes from baseline until 18 months of age | At 6, 9 and 12 months of age | 
| Developmental Milestones | Age-specific developmental milestones will be assessed | At 6, 12, and 18 months of age | 
| Cognitive and Motor Function | Using Bayley III | At 18 months of age | 
| Micronutrient Status | Iron, vitamin A, zinc and other micronutrient status of children will be examined by intervention group. | 18 months of age | 
| Intestinal Function | Intestinal function using L:M and other biomarkers will be assessed by intervention group and its association with child growth | At 24 months of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wasting, complementary food supplements, stunting, growth, Bangladesh, infant feeding