Complementary Food Supplements for Reducing Childhood Undernutrition

Johns Hopkins Bloomberg School of Public Health

Status and phase: Completed; Phase 3; Phase 2

Conditions: Wasting; Stunting

Treatments: Dietary Supplement: Rice based complementary food supplement; Dietary Supplement: Chickpea based complementary food supplement; Dietary Supplement: Plumpy Doz; Dietary Supplement: Wheat Soy Blend (WSB++)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01562379

00003703

NIFA210-38418-21732 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,449 patients

Sex: All

Ages: 6 to 8 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Infants 6 months of age

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,449 participants in 5 patient groups

No food

No Intervention group

Description:

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.

Plumpy Doz

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Plumpy Doz

Wheat Soy Blend (WSB++)

Experimental group

Description:

Children will receive a WFP-developed Wheat-Soy Blend (WSB++) snack to be consumed daily.

Treatment:

Dietary Supplement: Wheat Soy Blend (WSB++)

Chickpea based complementary food supplement

Experimental group

Description:

Children will receive a Chickpea based complementary food supplement to be consumed daily.

Treatment:

Dietary Supplement: Chickpea based complementary food supplement

Rice based complementary food supplement

Experimental group

Description:

Children will receive a locally developed rice based complementary food supplement.

Treatment:

Dietary Supplement: Rice based complementary food supplement