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

Infant Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04451395
• Other study ID #: 2020-3676-10314
• Status: Completed
• Phase: N/A
• Start date: August 5, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2021
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Milk Collection
• Infant Development

Intervention

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

Locations

Country	Name	City	State
Pakistan	Matiari Research and Training Centre	Matiari	Sindh

Sponsors (3)

Lead Sponsor	Collaborator
Aga Khan University	The Hospital for Sick Children, University of Toronto

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal BMI		3 months postpartum
Primary	Maternal dietary diversity score	Minimum score: 0, maximum score: 10	3 months postpartum
Primary	Maternal hemoglobin concentration		3 months postpartum
Primary	Maternal supplement adherence	Determined by report (options: 0, 25, 50, 75, or 100%)	3 months postpartum
Primary	Breastmilk macronutrient composition		3 months postpartum
Primary	Breastmilk micronutrient composition		3 months postpartum
Primary	Infant length		3 months postpartum
Secondary	Infant weight		3 months postpartum
Secondary	Infant middle-upper arm circumference		3 months postpartum
Secondary	Infant head circumference		3 months postpartum
Secondary	Breastmilk bioactive composition		3 months postpartum
Secondary	Breastmilk microbiome		3 months postpartum
Secondary	Infant microbiome		3 months postpartum