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Clinical Trials/NCT06641349
NCT06641349
Completed
N/A

Effect of Maternal Multiple Micronutrient Supplementation From Preconception Through Lactation on Child Growth and Development in Rural Pakistan: A Follow-up Study

University of Toronto1 site in 1 country150 target enrollmentJanuary 13, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
University of Toronto
Enrollment
150
Locations
1
Primary Endpoint
Full scale IQ score
Status
Completed
Last Updated
8 months ago

Overview

Brief Summary

The goal of this observational study is to learn about the long-term effects of maternal multiple micronutrient supplementation from preconception through to lactation on child neurodevelopment and growth in a resource-limited setting where there is a high burden of malnutrition. The main questions it aims to answer are:

  • Does maternal multiple micronutrient supplementation from preconception through to lactation compared to the standard of care have an effect on child neurodevelopment?
  • Does maternal multiple micronutrient supplementation from preconception through to lactation compared to the standard of care have an effect on child growth?

This is a cross-sectional follow up study to a substudy of breastmilk composition and infant growth within the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial, wherein mothers were randomized to receive a multiple micronutrient supplement from preconception through to lactation or the standard of care (ClinicalTrials.gov Identifier: NCT04451395).

Registry
clinicaltrials.gov
Start Date
January 13, 2025
End Date
June 4, 2025
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Deborah O'Connor

Chair, Department of Nutritional Sciences

University of Toronto

Eligibility Criteria

Inclusion Criteria

  • Child participated in the MaPPS Trial Breastmilk Sub-study at 3-months of age
  • Child has reached their fourth birthday
  • Child is available in the study catchment area (Matiari District)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Full scale IQ score

Time Frame: At 4 years of age

Wechsler Preschool and Primary Scale of Intelligence (WPPSI), minimum score: 40 and maximum score: 160 (higher scores mean a better outcome)

Secondary Outcomes

  • Fine and gross motor skills score(At 4 years of age)
  • Height(At 4 years of age)
  • Head circumference(At 4 years of age)

Study Sites (1)

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