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

Study Overview
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Brief Summary
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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).

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

Conditions
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Breast Milk Collection, Infant Development

Intervention / Treatment
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* Dietary Supplement: Multiple micronutrients (UNIMMAP composition)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multiple micronutrients (UNIMMAP composition)<br>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..The supplement is provided within the parent trial. Other Name: UNICEF, Micronutrient tabs, pregnancy/PAC-1000 | Dietary Supplement: Multiple micronutrients (UNIMMAP composition)<br>* 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<br>|
| No Intervention: Standard of care<br>Daily iron and folic acid supplementation provided through the existing public health system. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal BMI |  | 3 months postpartum | 
| Maternal dietary diversity score | Minimum score: 0, maximum score: 10 | 3 months postpartum | 
| Maternal hemoglobin concentration |  | 3 months postpartum | 
| Maternal supplement adherence | Determined by report (options: 0, 25, 50, 75, or 100%) | 3 months postpartum | 
| Breastmilk macronutrient composition |  | 3 months postpartum | 
| Breastmilk micronutrient composition |  | 3 months postpartum | 
| Infant length |  | 3 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant weight |  | 3 months postpartum | 
| Infant middle-upper arm circumference |  | 3 months postpartum | 
| Infant head circumference |  | 3 months postpartum | 
| Breastmilk bioactive composition |  | 3 months postpartum | 
| Breastmilk microbiome |  | 3 months postpartum | 
| Infant microbiome |  | 3 months postpartum |