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

NCT04451395 | Completed

• 1 other identifier: 2020-3676-10314
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Milk Collection; Infant Development

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• 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

Study Arms (2)

Multiple micronutrients (UNIMMAP composition)

EXPERIMENTAL

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)

Standard of care

NO INTERVENTION

Daily iron and folic acid supplementation provided through the existing public health system.

Interventions

Multiple micronutrients (UNIMMAP composition) DIETARY_SUPPLEMENT

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

Multiple micronutrients (UNIMMAP composition)

Eligibility Criteria

• Age: 15 Years - 25 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead
• The Hospital for Sick Children: collaborator
• University of Toronto: collaborator

Study Sites (1)

Matiari Research and Training Centre

Matiari, Sindh, Pakistan

Location

Related Publications (1)

• Baxter JB, Wasan Y, Daniel AI, Begum K, Hussain A, Iqbal J, Aufreiter S, Beggs MR, Duan L, Greco A, Huang C, Soofi S, Bandsma RH, Bhutta ZA, O'Connor DL. Maternal multiple micronutrient supplementation in rural Pakistan increased some milk micronutrient concentrations, but not infant growth, at three-months postpartum: a randomized controlled trial substudy. Am J Clin Nutr. 2025 Jul;122(1):174-184. doi: 10.1016/j.ajcnut.2025.05.019. Epub 2025 May 21.

  PMID: 40409469 DERIVED

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founding Chair, Centre of Excellence in Women and Child Health

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 30, 2020
• Study Start: August 5, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

PA (1)