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 |
|---|---|
| Ifakara Health Institute | OTHER |
| Harvard School of Public Health (HSPH) | OTHER |
| Muhimbili University of Health and Allied Sciences | OTHER |
| Africa Academy for Public Health |
Not provided
Not provided
Not provided
This is an individually randomized controlled trial to assess the effect of multiple micronutrient supplements (MMS) containing 60 and 45 mg iron as compared to MMS containing 30 mg of iron (standard UNIMMAP formulation) on maternal moderate or severe anemia. This study will help inform countries like Tanzania that currently use IFA containing 60 mg of iron regarding the dose of iron to use in MMS.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MMS with 30 mg iron | Active Comparator | MMS with standard UNIMMAP formulation of 15 micronutrients, including 30 mg of iron |
|
| MMS with 45 mg iron | Experimental | MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients |
|
| MMS with 60 mg iron | Experimental | MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple Micronutrient Supplements with 30 mg of elemental iron | Dietary Supplement | MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily from the time of randomization until delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of pregnant women with third-trimester moderate or severe anemia | Defined as a hemoglobin concentration <10 g/dL. | 3rd trimester (weeks 28-42 of pregnancy) |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal hemoglobin concentration | Continuous hemoglobin concentration measured from venous blood by complete blood count | 3rd trimester (weeks 28-42 of pregnancy) |
| Maternal hemoglobin concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Percent adherence | The percentage of days a pregnant woman takes a MMS pill out of the total number of days from randomization to delivery | During pregnancy (up to week 42) |
| Diarrhea | Self-reported any diarrhea symptoms during the intervention period |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily R Smith, ScD, MPH | Contact | 202-994-3589 | emilysmith@gwu.edu | |
| Christopher R Sudfeld, ScD, ScM | Contact | csudfeld@hsph.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Blair Wylie, MD, MPH | Columbia University | Principal Investigator |
| Honorati Masanja, PhD | Ifakara Health Institute | Principal Investigator |
| Alfa Muhihi, MD, MPH |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muhimbili University of Health and Allied Sciences | Recruiting | Dar es Salaam | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40517226 | Derived | Smith ER, Muhihi A, Wylie BJ, Mugusi S, Aboud S, Bakari M, Fawzi W, Kinyogoli S, Oakley EM, Pan Q, Sando MM, Brownlee VS, Pembe AB, Sudfeld CR, Masanja H. Multiple micronutrient supplementation for maternal anemia prevention (MMS-MAP): an individually randomized trial of higher-dose iron (60 mg, 45 mg) compared to low-dose iron (30 mg) in multiple micronutrient supplements in pregnancy. Trials. 2025 Jun 14;26(1):206. doi: 10.1186/s13063-025-08906-7. |
Not provided
Not provided
Not provided
| OTHER |
| Columbia University | OTHER |
Not provided
Not provided
Not provided
The trial is quadruple blind with all trial participants, outcome assessors (research staff and care providers), investigators, and trials statistician and data analysts being unable to determine the allocated trial arm for any trial participant or identify trial participants who are on the same trial regimen.
|
| Multiple Micronutrient Supplements with 45 mg of elemental iron | Dietary Supplement | MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization until delivery. |
|
| Multiple Micronutrient Supplements with 60 mg of elemental iron | Dietary Supplement | MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization until delivery. |
|
Continuous hemoglobin concentration measured from venous blood by complete blood count
| 6 weeks postpartum |
| Proportion of pregnant women with anemia | Hb concentration < 11 g/dL | 3rd trimester (weeks 28-42 of pregnancy) |
| Proportion of postpartum women with anemia | Hb concentration < 12 g/dL | 6 weeks postpartum |
| Maternal serum ferritin | Inflammation-adjusted serum ferritin | 3rd trimester (weeks 28-42 of pregnancy) |
| Proportion of pregnant women with iron deficiency | Inflammation-adjusted serum ferritin < 15 ug/L | 3rd trimester (weeks 28-42 of pregnancy) |
| Proportion of pregnant women with iron deficiency anemia | Anemia (Hb < 11 g/dL) and iron deficiency (inflammation-adjusted serum ferritin < 15 ug/L) | 3rd trimester (weeks 28-42 of pregnancy) |
| Proportion of women with preeclampsia | Gestational hypertension and gestational proteinuria among participants without chronic hypertension or gestational proteinuria among participants with chronic hypertension (superimposed preeclampsia) or clinical diagnosis of preeclampsia by managing clinical team or development of severe features of preeclampsia even in the absence of proteinuria | From 20 weeks gestation through delivery |
| Proportion of women with antepartum bleeding | Self-reported or clinical diagnosis of bleeding from or into the genital tract | From 24 weeks gestation through delivery |
| Proportion of women with postpartum hemorrhage | Clinical diagnosis of postpartum hemorrhage or use of critical interventions to treat postpartum hemorrhage | From delivery through 42 days post delivery |
| Proportion of women with infection-related severe maternal outcomes | Severe infection-related such as hospitalization for infection, women presenting with WHO near-miss criteria to define organ system dysfunction, invasive procedure to treat the source of infection (vacuum aspiration, dilatation and curettage, wound debridement, drainage, laparotomy and lavage, other surgery), or maternal death from infection. | During pregnancy through 42 days postpartum |
| Proportion of women with pregnancy-related death | Death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the cause of death | Pregnancy through 42 days of pregnancy termination |
| Proportion of women with symptoms consistent with depression | Patient Health Questionnaire-9 (PHQ-9) score ranging from 0 to 27, with higher scores consistent with depression and anxiety | 3rd trimester (weeks 28-42 of pregnancy) |
| Proportion of women with symptoms consistent with depression | Patient Health Questionnaire-9 (PHQ-9) score ranging from 0 to 27, with higher scores consistent with depression and anxiety | 6 weeks postpartum |
| Proportion of women with symptoms consistent with fatigue | FACIT assessment score ranging from 0 to 52, with lower scores consistent with fatigue. | 3rd trimester (weeks 28-42 of pregnancy) |
| Proportion of women with symptoms consistent with fatigue | FACIT assessment score ranging from 0 to 52, with lower scores consistent with fatigue. | 6 weeks postpartum |
| Proportion of women with malaria infection | Based on HRP2 biomarker or rapid-diagnostic tests (RDTs) | Pregnancy through 42 days postpartum |
| Proportion of fetal deaths | A product of human conception, irrespective of the duration of the pregnancy, which, after expulsion or extraction, does not breath or show any other evidence of life such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles, whether or not the umbilical cord has been cut or the placenta is attached | At pregnancy termination (weeks 1-42 of pregnancy) |
| Proportion of stillbirths | Fetal death ≥ 28 weeks gestation | At pregnancy termination (weeks 1-42 of pregnancy) |
| Birthweight | Continuous birthweight among live births | At birth |
| Proportion of live births with low birthweight | Live birth with birthweight < 2500 g | At birth |
| Gestational age at birth | Duration of gestation in weeks as a continuous measure among live births based on best obstetric estimate among live births | At birth |
| Proportion of preterm live births | Live birth <37 weeks gestation (based on best obstetric estimate) | At birth |
| Birthweight for gestational age | Continuous centile based on INTERGROWTH-21st standard birth centile among live births | At birth |
| Proportion of small-for-gestational age live births (<10th percentile) | Size-for-gestational age <10th on the INTERGROWTH-21st standard among live births | At birth |
| Proportion of small-for-gestational age live births (<3rd percentile) | Size-for-gestational age <3rd percentile on the INTERGROWTH-21st standard among live births | At birth |
| Infant hemoglobin concentration | Continuous Hb concentration measured from capillary blood by complete blood count | At 6 weeks of age |
| Infant serum ferritin | Continuous inflammation adjusted serum ferritin | At 6 weeks of age |
| Proportion of infants with iron deficiency | Inflammation-adjusted serum ferritin < 20 ug/L | At 6 weeks of age |
| Proportion of neonatal deaths | Death of liveborn infant during the first 28 completed days of life | From birth to 28 days of age |
| Proportion of infant deaths < 42 days | Death of a live born infant during the first 42 completed days of life | From birth to 42 days of age |
| During pregnancy (up to week 42) |
| Heartburn | Self-reported any heartburn symptoms during the intervention period | During pregnancy (up to week 42) |
| Constipation | Self-reported any constipation symptoms during the intervention period | During pregnancy (up to week 42) |
| Vomiting | Self-reported any vomiting symptoms during the intervention period | During pregnancy (up to week 42) |
| Nausea | Self-reported any nausea symptoms during the intervention period | During pregnancy (up to week 42) |
| Leg Cramps | Self-reported any leg cramps during the intervention period | During pregnancy (up to week 42) |
| Low back/pelvic pain | Self-reported any low back/pelvic pain during the intervention period | During pregnancy (up to week 42) |
| Maternal blood lead concentration | Continuous blood lead concentration measured from whole blood | 3rd trimester (weeks 28-42 of pregnancy) |
| Maternal plasma zinc concentration | Continuous zinc concentration measured from plasma | 3rd trimester (weeks 28-42 of pregnancy) |
| Africa Academy for Public Health |
| Principal Investigator |
| Andrea Pembe, MD, MMed, PhD, FCOG | Muhimbili University of Health and Allied Sciences | Principal Investigator |
| Emily R Smith, ScD, MPH | The Goerge Washington University | Principal Investigator |
| Christopher R Sudfeld, ScD, ScM | Harvard University | Principal Investigator |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided