Complementary Food Supplements for Reducing Childhood Undernutrition

Stunting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562379
• Other study ID #: 00003703
• Secondary ID: NIFA210-38418-21
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2012
• Est. completion date: November 2014

Study information

• Verified date: December 2017
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5449
• Est. completion date: November 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 8 Months

Eligibility

Inclusion Criteria:

• Infants 6 months of age

Related Conditions & MeSH terms

• Cachexia
• Growth Disorders
• Malnutrition
• Stunting
• Wasting

Intervention

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.
• Chickpea based complementary food supplement
A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals.
• Rice based complementary food supplement
Locally developed rice based complementary food with and added vitamins and minerals.
• Plumpy Doz
Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals.

Locations

Country	Name	City	State
Bangladesh	The JiVitA Project, Johns Hopkins Bangladesh	Gaibandha

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	DSM Ltd, International Centre for Diarrhoeal Disease Research, Bangladesh, United Nations World Food Programme (WFP)

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal Knowledge, Attitude and Practice Related to Infant and Young Child Feeding	Maternal KAP	At 6, 12 and 18 months of age
Primary	Stunting in Children at 18 mo	Prevalence of stunting at 18 months of age.	18 months of age
Secondary	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
Secondary	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
Secondary	Developmental Milestones	Age-specific developmental milestones will be assessed	At 6, 12, and 18 months of age
Secondary	Cognitive and Motor Function	Using Bayley III	At 18 months of age
Secondary	Micronutrient Status	Iron, vitamin A, zinc and other micronutrient status of children will be examined by intervention group.	18 months of age
Secondary	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