Dr. Mahbubur Rahman
Dhaka, 1212, Bangladesh
NCT Number: NCT04067284
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.
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Notify Me4 month–6 month
All sexes
Interventional
Not applicable
Dhaka, 1212, Bangladesh
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nutrition Education on
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.
No intervention/ control group
Time frame: Will be measured at baseline (6 months), 9 months and 12 months of child age
Child length converted to z-score
Time frame: Will be measured at baseline (6 months), 9 months and 12 months of child age
Child weight converted to z-score
Time frame: Will be measured at baseline (6 months), 9 months and 12 months of child age
Child head circumference
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.
Time frame: Will be measured at baseline (6 months), 9 months and 12 months of child age
International Centre for Diarrhoeal Disease Research, Bangladesh
Other
Does Early Initiation of Homemade Yogurt Supplementation Prevents Stunting - a Pilot Randomized Controlled Trial
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