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Clinical Trials/NCT04451395
NCT04451395
Completed
Not Applicable

Investigating Pathways Between Maternal Nutritional Status, Breastmilk Composition, and Infant Linear Growth in Rural Pakistan

Aga Khan University1 site in 1 country196 target enrollmentAugust 5, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Milk Collection
Sponsor
Aga Khan University
Enrollment
196
Locations
1
Primary Endpoint
Maternal BMI
Status
Completed
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 5, 2020
End Date
March 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Zulfiqar Ahmed Bhutta

Founding Chair, Centre of Excellence in Women and Child Health

Aga Khan University

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

Outcomes

Primary Outcomes

Maternal BMI

Time Frame: 3 months postpartum

Maternal dietary diversity score

Time Frame: 3 months postpartum

Minimum score: 0, maximum score: 10

Maternal hemoglobin concentration

Time Frame: 3 months postpartum

Maternal supplement adherence

Time Frame: 3 months postpartum

Determined by report (options: 0, 25, 50, 75, or 100%)

Breastmilk macronutrient composition

Time Frame: 3 months postpartum

Breastmilk micronutrient composition

Time Frame: 3 months postpartum

Infant length

Time Frame: 3 months postpartum

Secondary Outcomes

  • 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)

Study Sites (1)

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