Clinical trial NCT04451395: Investigating Pathways Between Maternal Nutritional Status, Breastmilk Composition, and Infant Linear Growth in Rural Pakistan
Official title: Investigating Pathways Between Maternal Nutritional Status, Breastmilk Composition, and Infant Linear Growth in Rural Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Milk Collection
Infant Development
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
name: University of Toronto
First posted: 2020-06-30
Enrollment: 196
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


Eligibility criteria: 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

Primary outcomes:
measure: Maternal BMI
timeFrame: 3 months postpartum
measure: Maternal dietary diversity score
timeFrame: 3 months postpartum
measure: Maternal hemoglobin concentration
timeFrame: 3 months postpartum
measure: Maternal supplement adherence
timeFrame: 3 months postpartum
measure: Breastmilk macronutrient composition
timeFrame: 3 months postpartum
measure: Breastmilk micronutrient composition
timeFrame: 3 months postpartum
measure: Infant length
timeFrame: 3 months postpartum
Secondary outcomes:
measure: Infant weight
timeFrame: 3 months postpartum
measure: Infant middle-upper arm circumference
timeFrame: 3 months postpartum
measure: Infant head circumference
timeFrame: 3 months postpartum
measure: Breastmilk bioactive composition
timeFrame: 3 months postpartum
measure: Breastmilk microbiome
timeFrame: 3 months postpartum
measure: Infant microbiome
timeFrame: 3 months postpartum
Other outcomes:
Locations:
city: Matiari
country: Pakistan
facility: Matiari Research and Training Centre
state: Sindh
Study officials:
References: