MedTrace Logo

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

NCT04451395 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2021-07-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • The Hospital for Sick Children

    collaborator OTHER

  • University of Toronto

    collaborator OTHER

  • Aga Khan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-05
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • Pakistan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04451395 on ClinicalTrials.gov