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NCT Number: NCT01562379

Complementary Food Supplements for Reducing Childhood Undernutrition

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.

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Key information

Conditions

Stunting Body Weight Body Weight Changes Cachexia Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Wasting Weight Loss

Age range

6 month–8 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The JiVitA Project, Johns Hopkins Bangladesh

Gaibandha, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants 6 months of age

Treatment and study plan

Wheat Soy Blend (WSB++)

Dietary Supplement

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

Chickpea based complementary food supplement

Dietary Supplement

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

Rice based complementary food supplement

Dietary Supplement

Locally developed rice based complementary food with and added vitamins and minerals.

Plumpy Doz

Dietary Supplement

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

Primary outcomes

  1. Stunting in Children at 18 mo

    Time frame: 18 months of age

    Prevalence of stunting at 18 months of age.

Secondary outcomes

  1. 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.

  2. 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

  3. Developmental Milestones

    Time frame: At 6, 12, and 18 months of age

    Age-specific developmental milestones will be assessed

  4. Cognitive and Motor Function

    Time frame: At 18 months of age

    Using Bayley III

  5. Micronutrient Status

    Time frame: 18 months of age

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

  6. 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

Other outcomes

  1. Maternal Knowledge, Attitude and Practice Related to Infant and Young Child Feeding

    Time frame: At 6, 12 and 18 months of age

    Maternal KAP

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 23, 2012
Registry last updated
Aug 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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