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| Name | Class |
|---|---|
| The Hospital for Sick Children | OTHER |
| University of Toronto | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple micronutrients (UNIMMAP composition) | Experimental | 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 |
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| Standard of care | No Intervention | Daily iron and folic acid supplementation provided through the existing public health system. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Infant weight | 3 months postpartum | |
| Infant middle-upper arm circumference | 3 months postpartum | |
| Infant head circumference |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Matiari Research and Training Centre | Matiari | Sindh | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40409469 | Derived | Baxter JB, Wasan Y, Daniel AI, Begum K, Hussain A, Iqbal J, Aufreiter S, Beggs MR, Duan L, Greco A, Huang C, Soofi S, Bandsma RH, Bhutta ZA, O'Connor DL. Maternal multiple micronutrient supplementation in rural Pakistan increased some milk micronutrient concentrations, but not infant growth, at three-months postpartum: a randomized controlled trial substudy. Am J Clin Nutr. 2025 Jul;122(1):174-184. doi: 10.1016/j.ajcnut.2025.05.019. Epub 2025 May 21. |
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Please contact the Primary Investigator directly for more details.
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|
| 3 months postpartum |
| Breastmilk bioactive composition | 3 months postpartum |
| Breastmilk microbiome | 3 months postpartum |
| Infant microbiome | 3 months postpartum |
| ID | Term |
|---|---|
| D061186 | Breast Milk Expression |
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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