Effect of Maternal Supplementation From Preconception to Lactation on Child Growth and Development

• Conditions: Malnutrition; Growth &Amp; Development

• Registration Number: NCT06641349
• Lead Sponsor: University of Toronto

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-11
• Study First Posted: 2024-10-15
• Study Start: 2025-01-13
• Status Verified: 2025-05
• Primary Completion: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Full scale IQ score	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 Outcome Measures

Name	Time	Method
Fine and gross motor skills score	At 4 years of age	Bruininks-Oseretsky Test of Motor Proficiency, 2nd edition (BOT-2) Brief Form, minimum score: 0 and maximum score: 80 (higher scores mean a better outcome)
Height	At 4 years of age
Head circumference	At 4 years of age

Trial Locations

Locations (1)

Aga Khan University; 🇵🇰 Matiari, Pakistan