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

Sponsor

Aga Khan University (Other)

Overall Status

Completed

CT.gov ID

NCT04451395

Collaborator

The Hospital for Sick Children (Other), University of Toronto (Other)

196

Enrollment

Location

Arms

7.8

Actual Duration (Months)

25.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Breast Milk Collection Infant Development	Dietary Supplement: Multiple micronutrients (UNIMMAP composition)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

196 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 5, 2020

Actual Primary Completion Date :

Mar 31, 2021

Actual Study Completion Date :

Mar 31, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 25 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Matiari Research and Training Centre	Matiari	Sindh	Pakistan

Sponsors and Collaborators

Aga Khan University
The Hospital for Sick Children
University of Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Zulfiqar Ahmed Bhutta, Founding Chair, Centre of Excellence in Women and Child Health, Aga Khan University

ClinicalTrials.gov Identifier:

NCT04451395

Other Study ID Numbers:

2020-3676-10314

First Posted:

Jun 30, 2020

Last Update Posted:

Jul 27, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Micronutrients

Trace Elements

Study Results

No Results Posted as of Jul 27, 2021