Investigating Pathways Between Maternal Nutritional Status, Breastmilk Composition, and Infant Linear Growth in Rural Pakistan
- Conditions
- Breast Milk CollectionInfant Development
- Interventions
- Dietary Supplement: Multiple micronutrients (UNIMMAP composition)
- Registration Number
- NCT04451395
- Lead Sponsor
- Aga Khan University
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 196
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multiple micronutrients (UNIMMAP composition) 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
- Primary Outcome Measures
Name Time Method Maternal BMI 3 months postpartum Maternal dietary diversity score 3 months postpartum Minimum score: 0, maximum score: 10
Maternal hemoglobin concentration 3 months postpartum Maternal supplement adherence 3 months postpartum Determined by report (options: 0, 25, 50, 75, or 100%)
Breastmilk macronutrient composition 3 months postpartum Breastmilk micronutrient composition 3 months postpartum Infant length 3 months postpartum
- Secondary Outcome Measures
Name Time Method 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 Breastmilk microbiome 3 months postpartum Infant microbiome 3 months postpartum
Trial Locations
- Locations (1)
Matiari Research and Training Centre
🇵🇰Matiari, Sindh, Pakistan