Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Hospital for Sick Children | OTHER |
| National Program for Family Planning and Primary Health Care | UNKNOWN |
| Bill and Melinda Gates Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
The primary aims of this study are: 1) To evaluate the impact of supplementation with multiple micronutrients (MMN) from preconception and life skills education among women 15-18.9 years of age at enrolment on the prevalence of anemia in a population setting; and 2) To evaluate the impact of supplementation with MMN from preconception and life skills education among young women 15-24 years of age on the rate of low birth weight (LBW) in a population setting. Infants born to mothers enrolled in the study will be followed for 1 year. This study aims to enrol 25,400 non-pregnant young women in Matiari district. This sample size is anticipated to equate to 1456 births. Participants will be randomized by cluster to receive either MMN supplements and life skills education or the standard of care at enrolment. Clusters have been defined based on health facility catchment areas. MMN supplements will be provided twice weekly during the preconception period, once daily during the pregnancy period, and once daily until 6 months after giving birth during the postpartum period; and a package of life skills education materials will be provided bi-monthly during the preconception period. In addition to the primary outcomes, measurements will include micronutrient status, anthropometrics, birth outcomes, dietary intake and feeding practices, adherence, and indices of empowerment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | No Intervention |
| |
| MMN supplementation and life skills education | Experimental |
|
|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Anemia status | Hemoglobin concentration <12 g/dL | 0, 12*, 24 months (*in subgroup only) |
| Low birth weight | Birth weight <2500 g | At birth |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers: serum ferritin, serum transferrin receptor, hepcidin, serum retinol, serum 25(OH)D, alpha-glycolytic protein, C-reactive protein (women) | Preconception (subgroup only): enrolment, 1 year, 2 years; Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week | |
| Anthropometrics: height (women) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zulfiqar A Bhutta, PhD, MBBS | Aga Khan University | Principal Investigator |
| 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. | |
| 37221027 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Some investigators are blinded to the allocation of the intervention, and all study data collectors are blinded.
|
|
| Life skills based education | Behavioral | The life skills based education will be provided bi-monthly in the format of a group session throughout the preconception period. Three topic areas related to empowerment have been prioritized, including preventing early marriage; personal and menstrual hygiene practices; and the importance of nutrition to good health. Integrated within these topics will be messages related to the importance of continuing one's education, mental health, gender norms and equality, decision making, advocacy, resiliency, participation, communication skills, facing challenges, agency, conflict resolution, and the prevention of violence. |
|
| Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months |
| Anthropometrics: middle upper arm circumference (women) | Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months |
| Anthropometrics: weight (women) | Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months |
| Gestational age | At birth |
| Preterm birth | At birth |
| Stillbirth | At birth |
| Small for gestational age | At birth |
| Birth size: length | Within 24 hours of birth |
| Birth size: head circumference | Within 24 hours of birth |
| Birth size: middle upper arm circumference | Within 24 hours of birth |
| Birth size: weight | Within 24 hours of birth |
| Birth defects | At birth |
| Infant growth: length | 1, 3, 6, 9, 12 months |
| Infant growth: head circumference | 1, 3, 6, 9, 12 months |
| Infant growth: middle upper arm circumference | 1, 3, 6, 9, 12 months |
| Infant growth: weight | 1, 3, 6, 9, 12 months |
| Age at marriage | Enrolment, 1 year, 2 years |
| Completion of 10th grade education | Enrolment, 1 year, 2 years |
| Use of sanitary pad during last menstrual period | Enrolment, 1 year, 2 years |
| Dietary intake: 24-hour recall (subgroup of women) | Preconception: enrolment; Pregnancy: 4-12 weeks, 32 weeks |
| Derived |
| Baxter JB, Wasan Y, Hussain A, Soofi SB, Ahmed I, Bhutta ZA. Drivers of malnutrition among late adolescent and young women in rural Pakistan: a cross-sectional assessment of the MaPPS trial. BMJ Open. 2023 May 23;13(5):e063734. doi: 10.1136/bmjopen-2022-063734. |
| 34901693 | Derived | Baxter JB, Kortenaar JL, Wasan Y, Hussain A, Soofi SB, Ahmed I, Bhutta ZA. Age-Based Anthropometric Cutoffs Provide Inconsistent Estimates of Undernutrition: Findings from a Cross-Sectional Assessment of Late-Adolescent and Young Women in Rural Pakistan. Curr Dev Nutr. 2021 Nov 10;5(11):nzab130. doi: 10.1093/cdn/nzab130. eCollection 2021 Nov. |
| 31367763 | Derived | Bhutta ZA. Reply to NF Krebs and KM Hambidge. Am J Clin Nutr. 2019 Aug 1;110(2):521-522. doi: 10.1093/ajcn/nqz078. No abstract available. |
| 30721972 | Derived | Bhutta ZA. Balancing the benefits of maternal nutritional interventions; time to put women first! Am J Clin Nutr. 2019 Feb 1;109(2):249-250. doi: 10.1093/ajcn/nqy336. No abstract available. |
| 29855317 | Derived | Baxter JB, Wasan Y, Soofi SB, Suhag Z, Bhutta ZA. Effect of life skills building education and micronutrient supplements provided from preconception versus the standard of care on low birth weight births among adolescent and young Pakistani women (15-24 years): a prospective, population-based cluster-randomized trial. Reprod Health. 2018 May 31;15(1):104. doi: 10.1186/s12978-018-0545-0. |
| 29848335 | Derived | Baxter JB, Wasan Y, Soofi SB, Suhag Z, Bhutta ZA. Feasibility and effect of life skills building education and multiple micronutrient supplements versus the standard of care on anemia among non-pregnant adolescent and young Pakistani women (15-24 years): a prospective, population-based cluster-randomized trial. Reprod Health. 2018 May 30;15(1):103. doi: 10.1186/s12978-018-0547-y. |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D000079102 | Empowerment |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D014480 | United Nations |
| ID | Term |
|---|---|
| D007390 | International Agencies |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
Not provided
Not provided