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

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).

Study Overview

• Status: Completed
• Conditions: Infant Development; Breast Milk Collection
• Intervention / Treatment: Dietary supplement: Multiple micronutrients (UNIMMAP composition)

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Matiari, Sindh, Pakistan
      • Matiari Research and Training Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: 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. Other Name: UNICEF, Micronutrient tabs, pregnancy/PAC-1000
No Intervention: Standard of care; Daily iron and folic acid supplementation provided through the existing public health system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal BMI		3 months postpartum
Maternal dietary diversity score	Minimum score: 0, maximum score: 10	3 months postpartum
Maternal hemoglobin concentration		3 months postpartum
Maternal supplement adherence	Determined by report (options: 0, 25, 50, 75, or 100%)	3 months postpartum
Breastmilk macronutrient composition		3 months postpartum
Breastmilk micronutrient composition		3 months postpartum
Infant length		3 months postpartum

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Aga Khan University
• Collaborators: The Hospital for Sick Children; University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2020
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Trace Elements
• Other Study ID Numbers: 2020-3676-10314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Please contact the Primary Investigator directly for more details.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No