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

August 20, 2025 updated by: Deborah O'Connor, University of Toronto

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

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Matiari, Pakistan
        • Aga Khan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Residence within Matiari District, Pakistan

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Children born to mothers who received a multiple micronutrient supplement
From preconception to 6-months postpartum, mothers received a multiple micronutrient supplement (oral tablet at UNIMMAP composition [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])
Children born to mothers who received the standard of care
From preconception to 6-months postpartum, mothers received the standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At 4 years of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height
Time Frame: At 4 years of age
At 4 years of age
Head circumference
Time Frame: At 4 years of age
At 4 years of age
Fine and gross motor skills score
Time Frame: 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)
At 4 years of age

Other Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: At 4 years of age
At 4 years of age
Middle upper arm circumference
Time Frame: At 4 years of age
At 4 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Collaborators

Aga Khan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2025

Primary Completion (Actual)

June 4, 2025

Study Completion (Actual)

June 4, 2025

Study Registration Dates

First Submitted

October 11, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46670

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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