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Completed

NCT Number: NCT04451395

Investigating Pathways Between Maternal Nutritional Status, Breastmilk Composition, and Infant Linear Growth in Rural Pakistan

Breastmilk is considered optimal for infant growth and development. However, evidence suggests that breastmilk composition can vary according to maternal nutritional status. Among women in Pakistan, there is a high burden of undernutrition and micronutrient deficiencies. As well, the prevalence of early stunting among Pakistani infants is high. Using a hypothesized pathway model, this study will assess pathways between maternal nutritional status, breastmilk composition, and infant linear growth. This is a substudy to the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial (ClinicalTrials.gov Identifier: NCT03287882).

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Key information

Conditions

Breast Milk Collection Behavior Breast Feeding Breast Milk Expression Feeding Behavior Infant Development

Age range

15 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Matiari Research and Training Centre

Matiari, Sindh, Pakistan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Enrolled in the MaPPS Trial
  • Mothers must report practicing exclusive or predominant breastfeeding (i.e., breastmilk only or breastmilk and non-nutritive feeds only)
  • The infant must be term-born (>37 weeks gestation)
  • Infant must be 3 months ± 30 days old at the time of recruitment
  • Mothers must be willing to provide a complete breastmilk expression from one breast
  • Intervention arm only: mother reports compliance with study-administered MMN supplements at least 50% of the time (i.e., 4 out of 7 days per week)
  • Able to provide informed consent

Exclusion criteria

  • Mother reports mixed feeding in her infant with nutritive feeds (i.e., any provision of formula or animal milk)
  • The infant was born preterm (earlier than 37 weeks gestation)
  • Mother does not wish to provide a complete breast expression of one breast
  • Intervention arm: mother reports compliance with MMN supplements <50% of the time

Treatment and study plan

Multiple micronutrients (UNIMMAP composition)

Dietary Supplement

The intervention is an oral tablet containing 15 different vitamins and minerals at the UNIMMAP composition (includes 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). Each tablet is small (approximately 10 mm diameter) and has been procured using the UNICEF supply catalogue. A single MMN supplementation dose will consist of a single tablet.

Other Name: UNICEF, Micronutrient tabs, pregnancy/PAC-1000

Primary outcomes

  1. Maternal BMI

    Time frame: 3 months postpartum

  2. Maternal dietary diversity score

    Time frame: 3 months postpartum

    Minimum score: 0, maximum score: 10

  3. Maternal hemoglobin concentration

    Time frame: 3 months postpartum

  4. Maternal supplement adherence

    Time frame: 3 months postpartum

    Determined by report (options: 0, 25, 50, 75, or 100%)

  5. Breastmilk macronutrient composition

    Time frame: 3 months postpartum

  6. Breastmilk micronutrient composition

    Time frame: 3 months postpartum

  7. Infant length

    Time frame: 3 months postpartum

Secondary outcomes

  1. Infant weight

    Time frame: 3 months postpartum

  2. Infant middle-upper arm circumference

    Time frame: 3 months postpartum

  3. Infant head circumference

    Time frame: 3 months postpartum

  4. Breastmilk bioactive composition

    Time frame: 3 months postpartum

  5. Breastmilk microbiome

    Time frame: 3 months postpartum

  6. Infant microbiome

    Time frame: 3 months postpartum

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • The Hospital for Sick Children
  • University of Toronto

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 30, 2020
Registry last updated
Jul 27, 2021

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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