Investigating Pathways Between Maternal Nutritional Status, Breastmilk Composition, and Infant Linear Growth in Rural Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Maternal BMI
研究概览
简要总结
Breastmilk is considered optimal for infant growth and development. However, evidence suggests that breastmilk composition can vary according to maternal nutritional status. Among women in Pakistan, there is a high burden of undernutrition and micronutrient deficiencies. As well, the prevalence of early stunting among Pakistani infants is high. Using a hypothesized pathway model, this study will assess pathways between maternal nutritional status, breastmilk composition, and infant linear growth. This is a substudy to the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial (ClinicalTrials.gov Identifier: NCT03287882).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Enrolled in the MaPPS Trial
- •Mothers must report practicing exclusive or predominant breastfeeding (i.e., breastmilk only or breastmilk and non-nutritive feeds only)
- •The infant must be term-born (>37 weeks gestation)
- •Infant must be 3 months ± 30 days old at the time of recruitment
- •Mothers must be willing to provide a complete breastmilk expression from one breast
- •Intervention arm only: mother reports compliance with study-administered MMN supplements at least 50% of the time (i.e., 4 out of 7 days per week)
- •Able to provide informed consent
排除标准
- •Mother reports mixed feeding in her infant with nutritive feeds (i.e., any provision of formula or animal milk)
- •The infant was born preterm (earlier than 37 weeks gestation)
- •Mother does not wish to provide a complete breast expression of one breast
- •Intervention arm: mother reports compliance with MMN supplements <50% of the time
研究组 & 干预措施
Multiple micronutrients (UNIMMAP composition)
The intervention is an oral tablet containing 15 different vitamins and minerals at the UNIMMAP composition (includes 30 mg iron, 400 μg folic acid, 15 mg zinc, 2 mg copper, 65 μg selenium, 800 μg RE vitamin A, 1.4 mg vitamin B1, 1.4 mg vitamin B2, 18 mg niacin, 1.9 mg vitamin B6, 2.6 μg vitamin B12, 70 mg vitamin C, 5 μg vitamin D, 10 mg vitamin E and 150 μg iodine). Each tablet is small (approximately 10 mm diameter) and has been procured using the UNICEF supply catalogue. A single MMN supplementation dose will consist of a single tablet..The supplement is provided within the parent trial.
Other Name: UNICEF, Micronutrient tabs, pregnancy/PAC-1000
干预措施: Multiple micronutrients (UNIMMAP composition) (Dietary Supplement)
Standard of care
Daily iron and folic acid supplementation provided through the existing public health system.
结局指标
主要结局
Maternal BMI
时间窗: 3 months postpartum
Maternal dietary diversity score
时间窗: 3 months postpartum
Minimum score: 0, maximum score: 10
Maternal hemoglobin concentration
时间窗: 3 months postpartum
Maternal supplement adherence
时间窗: 3 months postpartum
Determined by report (options: 0, 25, 50, 75, or 100%)
Breastmilk macronutrient composition
时间窗: 3 months postpartum
Breastmilk micronutrient composition
时间窗: 3 months postpartum
Infant length
时间窗: 3 months postpartum
次要结局
- Breastmilk microbiome(3 months postpartum)
- Infant microbiome(3 months postpartum)
- Infant weight(3 months postpartum)
- Infant middle-upper arm circumference(3 months postpartum)
- Infant head circumference(3 months postpartum)
- Breastmilk bioactive composition(3 months postpartum)
研究者
Dr Zulfiqar Ahmed Bhutta
Founding Chair, Centre of Excellence in Women and Child Health
Aga Khan University