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

University of Toronto

Status: Completed

Conditions: Malnutrition; Growth &Amp; Development

Study type: Observational

Funder types: Other

Identifiers

NCT06641349

46670

Details and patient eligibility

About

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).

Enrollment: 150 patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

150 participants in 2 patient groups

Children born to mothers who received a multiple micronutrient supplement

Description:

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

Description:

From preconception to 6-months postpartum, mothers received the standard of care