- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04067284
Homemade Yogurt Supplementation to Prevent Stunting
Does Early Initiation of Homemade Yogurt Supplementation Prevents Stunting - a Pilot Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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).
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Dhaka, Bangladesh, 1212
- Dr. Mahbubur Rahman
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Infants at risk of developing stunting aged 5 months (-1SD LAZ)
- All gender, religion, language and ethnicity
- Infants born through normal delivery or cesarean section
- Breastfeeding or non-breastfeeding
Exclusion Criteria:
- Stunting or wasting (<-2SD LAZ)
- Infants with any major congenital abnormality or any chronic conditions (e.g., rheumatic heart disease)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Education
Nutrition education on dietary diversity.
|
Nutrition Education on
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EXPERIMENTAL: Yogurt
A combination of similar education plus daily supplementation of homemade yogurt
|
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.
|
ACTIVE_COMPARATOR: Control
Control group.
|
No intervention/ control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline (6 months) length for age z-score (LAZ) at 9 months and 12 months of child age.
Time Frame: Will be measured at baseline (6 months), 9 months and 12 months of child age
|
Child length converted to z-score
|
Will be measured at baseline (6 months), 9 months and 12 months of child age
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline (6 months) weight for age z-score (WAZ) at 9 months and 12 months of child age.
Time Frame: Will be measured at baseline (6 months), 9 months and 12 months of child age
|
Child weight converted to z-score
|
Will be measured at baseline (6 months), 9 months and 12 months of child age
|
Change from baseline (6 months) mean head circumference at 9 months and 12 months of child age.
Time Frame: Will be measured at baseline (6 months), 9 months and 12 months of child age
|
Child head circumference
|
Will be measured at baseline (6 months), 9 months and 12 months of child age
|
Change from baseline (6 months) mean concentration of fecal bio-markers at 9 months and 12 months of child age.
Time Frame: Will be measured at baseline (6 months), 9 months and 12 months of child age
|
Concentration of neopterin, myeloperoxidase, and alpha 1 antitrypsin in stool samples.
|
Will be measured at baseline (6 months), 9 months and 12 months of child age
|
Change from baseline (6 months) proportion of children meeting food diversity scores at 9 months and 12 months of child age.
Time Frame: Will be measured at baseline (6 months), 9 months and 12 months of child age
|
|
Will be measured at baseline (6 months), 9 months and 12 months of child age
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR-19062
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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