Does Early Initiation of Homemade Yogurt Supplementation Prevents Stunting - a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change from baseline (6 months) length for age z-score (LAZ) at 9 months and 12 months of child age.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Stunting or wasting (<-2SD LAZ)
- •Infants with any major congenital abnormality or any chronic conditions (e.g., rheumatic heart disease)
结局指标
主要结局
Change from baseline (6 months) length for age z-score (LAZ) at 9 months and 12 months of child age.
时间窗: Will be measured at baseline (6 months), 9 months and 12 months of child age
Child length converted to z-score
次要结局
- Change from baseline (6 months) mean concentration of fecal bio-markers at 9 months and 12 months of child age.(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.(Will be measured at baseline (6 months), 9 months and 12 months of child age)
- Change from baseline (6 months) weight for age z-score (WAZ) at 9 months and 12 months of child age.(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.(Will be measured at baseline (6 months), 9 months and 12 months of child age)