Homemade Yogurt Supplementation to Prevent Stunting

International Centre for Diarrhoeal Disease Research (icddr,b)

Status: Completed

Conditions: Child Malnutrition

Treatments: Behavioral: Nutrition education; Dietary Supplement: Homemade yogurt supplementation; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04067284

PR-19062

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 4 to 6 months old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 3 patient groups

Education

Active Comparator group

Description:

Nutrition education on dietary diversity.

Treatment:

Behavioral: Nutrition education

Yogurt

Experimental group

Description:

A combination of similar education plus daily supplementation of homemade yogurt

Treatment:

Dietary Supplement: Homemade yogurt supplementation

Control

Active Comparator group

Description:

Control group.

Treatment:

Other: Usual care