A Phase 3 interventional study of Multiple Micronutrient Supplements with 30 mg of elemental iron and Multiple Micronutrient Supplements with 45 mg of elemental iron in Pregnancy Related, sponsored by George Washington University. Recruiting at 1 site in Tanzania. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by George Washington University · Phase 3, Interventional, and Prevention
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.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's planned enrollment of 6,381 is above the median of 117 across 1,336 interventional studies indexed under Anemia.
Browse Anemia studies →George Washington University is the lead sponsor of 192 studies on the registry; 34 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMS with standard UNIMMAP formulation of 15 micronutrients, including 30 mg of iron
Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron
MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients
Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron
MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients
Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron
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.
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.
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.
Proportion of pregnant women with third-trimester moderate or severe anemia
Defined as a hemoglobin concentration \<10 g/dL.
Time frame: 3rd trimester (weeks 28-42 of pregnancy)
Maternal hemoglobin concentration
Continuous hemoglobin concentration measured from venous blood by complete blood count
Time frame: 3rd trimester (weeks 28-42 of pregnancy)
Maternal hemoglobin concentration
Continuous hemoglobin concentration measured from venous blood by complete blood count
Time frame: 6 weeks postpartum
Proportion of pregnant women with anemia
Hb concentration \< 11 g/dL
Time frame: 3rd trimester (weeks 28-42 of pregnancy)
Proportion of postpartum women with anemia
Hb concentration \< 12 g/dL
Time frame: 6 weeks postpartum
Maternal serum ferritin
Inflammation-adjusted serum ferritin
Time frame: 3rd trimester (weeks 28-42 of pregnancy)
Proportion of pregnant women with iron deficiency
Inflammation-adjusted serum ferritin \< 15 ug/L
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks postpartum
Proportion of women with malaria infection
Based on HRP2 biomarker or rapid-diagnostic tests (RDTs)
Time frame: 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
Time frame: At pregnancy termination (weeks 1-42 of pregnancy)
Proportion of stillbirths
Fetal death ≥ 28 weeks gestation
Time frame: At pregnancy termination (weeks 1-42 of pregnancy)
Birthweight
Continuous birthweight among live births
Time frame: At birth
Proportion of live births with low birthweight
Live birth with birthweight \< 2500 g
Time frame: 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
Time frame: At birth
Proportion of preterm live births
Live birth \<37 weeks gestation (based on best obstetric estimate)
Time frame: At birth
Birthweight for gestational age
Continuous centile based on INTERGROWTH-21st standard birth centile among live births
Time frame: 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
Time frame: 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
Time frame: At birth
Infant hemoglobin concentration
Continuous Hb concentration measured from capillary blood by complete blood count
Time frame: At 6 weeks of age
Infant serum ferritin
Continuous inflammation adjusted serum ferritin
Time frame: At 6 weeks of age
Proportion of infants with iron deficiency
Inflammation-adjusted serum ferritin \< 20 ug/L
Time frame: At 6 weeks of age
Proportion of neonatal deaths
Death of liveborn infant during the first 28 completed days of life
Time frame: 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
Time frame: From birth to 42 days of age
Percent adherence
The percentage of days a pregnant woman takes a MMS pill out of the total number of days from randomization to delivery
Time frame: During pregnancy (up to week 42)
Diarrhea
Self-reported any diarrhea symptoms during the intervention period
Time frame: During pregnancy (up to week 42)
Heartburn
Self-reported any heartburn symptoms during the intervention period
Time frame: During pregnancy (up to week 42)
Constipation
Self-reported any constipation symptoms during the intervention period
Time frame: During pregnancy (up to week 42)
Vomiting
Self-reported any vomiting symptoms during the intervention period
Time frame: During pregnancy (up to week 42)
Nausea
Self-reported any nausea symptoms during the intervention period
Time frame: During pregnancy (up to week 42)
Leg Cramps
Self-reported any leg cramps during the intervention period
Time frame: During pregnancy (up to week 42)
Low back/pelvic pain
Self-reported any low back/pelvic pain during the intervention period
Time frame: During pregnancy (up to week 42)
Maternal blood lead concentration
Continuous blood lead concentration measured from whole blood
Time frame: 3rd trimester (weeks 28-42 of pregnancy)
Maternal plasma zinc concentration
Continuous zinc concentration measured from plasma
Time frame: 3rd trimester (weeks 28-42 of pregnancy)
Started Mar 2025 (actual). Primary completion is estimated for Mar 2027, 24 months after the start.
Of 52 non-industry phase 3 interventional studies under Anemia, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 24 months is below that.
Counting every sponsor, half of 150 studies reached it within 30 months; a quarter within 17 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
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