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Completed

NCT Number: NCT06641349

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

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).

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Key information

Conditions

Malnutrition Growth &Amp; Development Nutrition Disorders Nutritional and Metabolic Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aga Khan University

Matiari, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

  1. 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)

  2. Height

    Time frame: At 4 years of age

  3. Head circumference

    Time frame: At 4 years of age

Other outcomes

  1. Weight

    Time frame: At 4 years of age

  2. Middle upper arm circumference

    Time frame: At 4 years of age

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Aga Khan University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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