Breast Milk Collection, Infant Development
Conditions
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).
Interventions
DIETARY_SUPPLEMENTMultiple 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. Other Name: UNICEF, Micronutrient tabs, pregnancy/PAC-1000
Sponsors
The Hospital for Sick Children
University of Toronto
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant length | 3 months postpartum | — |
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Infant weight | 3 months postpartum |
Countries
Pakistan
Outcome results
None listed