Complementary Food Supplements for Reducing Childhood Undernutrition

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

International Centre for Diarrhoeal Disease Research, Bangladesh, United Nations World Food Programme (WFP), DSM Ltd

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.

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.

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.

In this control arm children will receive prepackaged, lipid-based Plumpy'Doz (Nutriset, Mulaunay, France) for daily consumption as a snack.

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

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

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

weekly morbidity will be assessed for a year and episodes of diarrhea, dysentery ALRI, and fever will be recorded.

Bioelectrical impedance analysis will be used to look at body composition changes from baseline until 18 months of age

Iron, vitamin A, zinc and other micronutrient status of children will be examined by intervention group.

Intestinal function using L:M and other biomarkers will be assessed by intervention group and its association with child growth

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