Clinical trial NCT04067284: Homemade Yogurt Supplementation to Prevent Stunting
Official title: Does Early Initiation of Homemade Yogurt Supplementation Prevents Stunting - a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Malnutrition
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: University of Western Sydney
First posted: 2019-08-26
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A three-arm randomized controlled trial in Dhaka's slum area is proposed. 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 randomised 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. We will recruit 120 children (40 per arm).
Primary purpose: PREVENTION

Brief 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.

Detailed description: Hypothesis:

The investigators hypothesize that, continued breastfeeding, adequate complimentary feeding and supplementation with homemade yogurt have the potential to reduce stunting.

Primary objective:

The present study is aimed to assess the impact of low-cost nutritional strategies to prevent childhood malnutrition in Bangladesh.

Specific objectives:

1. To compare differences in growth pattern (length-for-age z-score, weight-for age z-score, head circumference) of children at risk of stunting age 6-months between infants receiving educational program only, infants receiving education plus homemade yogurt supplementation and those receiving the "usual-care" (control).
2. To evaluate whether amount of gut microbiota necessary to improve gut health was associated with weight gain and growth in these children to support the casual mechanism behind this approach.

Eligibility criteria: Inclusion Criteria:

1. Infants at risk of developing stunting aged 5 months (-1SD LAZ)
2. All gender, religion, language and ethnicity
3. Infants born through normal delivery or cesarean section
4. Breastfeeding or non-breastfeeding

Exclusion Criteria:

1. Stunting or wasting (\<-2SD LAZ)
2. Infants with any major congenital abnormality or any chronic conditions (e.g., rheumatic heart disease)

Primary outcomes:
measure: Change from baseline (6 months) length for age z-score (LAZ) at 9 months and 12 months of child age.
timeFrame: Will be measured at baseline (6 months), 9 months and 12 months of child age
Secondary outcomes:
measure: Change from baseline (6 months) weight for age z-score (WAZ) at 9 months and 12 months of child age.
timeFrame: Will be measured at baseline (6 months), 9 months and 12 months of child age
measure: Change from baseline (6 months) mean head circumference at 9 months and 12 months of child age.
timeFrame: Will be measured at baseline (6 months), 9 months and 12 months of child age
measure: Change from baseline (6 months) mean concentration of fecal bio-markers at 9 months and 12 months of child age.
timeFrame: Will be measured at baseline (6 months), 9 months and 12 months of child age
measure: Change from baseline (6 months) proportion of children meeting food diversity scores at 9 months and 12 months of child age.
timeFrame: Will be measured at baseline (6 months), 9 months and 12 months of child age
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Dr. Mahbubur Rahman
Study officials:
References: