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

Aga Khan University

Status: Completed

Conditions: Infant Development; Breast Milk Collection

Treatments: Dietary Supplement: Multiple micronutrients (UNIMMAP composition)

Study type: Interventional

Funder types: Other

Identifiers

NCT04451395

2020-3676-10314

Details and patient eligibility

About

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).

Enrollment: 196 patients

Sex: Female

Ages: 15 to 25 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

Multiple micronutrients (UNIMMAP composition)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Multiple micronutrients (UNIMMAP composition)

Standard of care

No Intervention group

Description:

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