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

NCT ID: NCT04451395

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-05
• Study Completion Date: 2021-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Multiple micronutrients (UNIMMAP composition)

Intervention Type: 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

Standard of care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Dr Zulfiqar Ahmed Bhutta

Founding Chair, Centre of Excellence in Women and Child Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Matiari Research and Training Centre

Matiari, Sindh, Pakistan

Countries

Pakistan

References

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.

Reference Type: DERIVED

PMID: 40409469 (View on PubMed)

Other Identifiers

2020-3676-10314

Identifier Type: -

Identifier Source: org_study_id