NCT04451395

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Aga Khan University · Academic / Other
• Sex: Female
• Age: 15 Years – 25 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-08-05
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2020-06-30
• Last updated: 2021-07-27

Locations

1 site across 1 country: Pakistan