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Homemade Yogurt Supplementation to Prevent Stunting

NCT04067284 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-03-08

No results posted yet for this study

Summary

Stunting contributes substantially to child mortality and disease burden in low-income countries. In Bangladesh the prevalence of stunting among children \<5-years of age is high (36%) reaching 50% in slum areas. The pathogenesis of stunting is multifaceted, yet nutritional inadequacy and repeated infections are established risk factors of stunting.

A three-arm randomized controlled trial in Dhaka's slum area is proposed. The children will be recruited from vaccination clinics. Infants at risk of stunting (-1 SD length-for-age z-score, LAZ) aged around 5 months are eligible for the study. Eligible children will be randomized to receive: 1) nutrition education on dietary diversity; 2) a combination of similar education plus daily supplementation of homemade yogurt; 3) a 'usual care' (control) group. The investigators will recruit 120 children (40 per arm). Intervention will be initiated a month before starting of complementary feeding with an educational session and will last 7 months during which a monthly educational session will be delivered at participant's household. The homemade yogurt supplementation will start a week after beginning of 6 months of age once the child is introduced to solid foods of the mother's choice. The yogurt will be supplied to the mothers every day at time of feeding. Feeding behaviors will be self-monitored using a pictorial calendar. Primary outcome (LAZ) and secondary outcomes (fecal bio-markers, WAZ, head circumference, and food diversity scores), will be measured at baseline (6 months), 9 months and 12 months of child age. Supplementation with homemade yogurt is a novel approach with the potential to improve infant gut environment, improve food absorption and thus potentially prevent stunting.

Conditions

  • Child Malnutrition

Interventions

BEHAVIORAL

Nutrition education

Nutrition Education on * Continued breastfeeding until two years of age * Food groups * Balanced diet * Introduction to locally available nutritious and low-cost foods * Amount and frequency of complementary feeding * Safe water, and * Handwashing with soap before feeding

DIETARY_SUPPLEMENT

Homemade yogurt supplementation

The homemade yogurt supplementation will start a week after beginning of 6 months of age once the child is introduced to solid foods of the mother's choice. The yogurt will be supplied to the mothers every day at time of feeding.

OTHER

Usual care

No intervention/ control group

Sponsors & Collaborators

  • University of Western Sydney

    collaborator OTHER

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04067284 on ClinicalTrials.gov