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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06079918
Other study ID # MMS-MAP
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date September 2024
Est. completion date September 2025

Study information

Verified date March 2024
Source George Washington University
Contact Emily R Smith, ScD, MPH
Phone +1 2029943589
Email emilysmith@gwu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 6381
Est. completion date September 2025
Est. primary completion date June 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Attending first ANC visit at study clinics - Pregnant women < 20 weeks gestation (up to 19 weeks and 6 days) by last menstrual period (LMP) - Aged = 18 years old - Intending to stay in Dar es Salaam until 6 weeks post delivery - Provides informed consent Exclusion Criteria: - Severe anemia (defined as hemoglobin < 8.5 g/dL per Tanzania standard of care) - Sickle cell disease (SS and SC) and hemoglobin C disease (CC) as tested by HemoTypeSC - Concurrently enrolled in another nutritional clinical trial

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Multiple Micronutrient Supplements with 30 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.
Multiple Micronutrient Supplements with 45 mg of elemental iron
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
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.

Locations

Country Name City State
n/a

Sponsors (6)

Lead Sponsor Collaborator
George Washington University Africa Academy for Public Health, Columbia University, Harvard School of Public Health (HSPH), Ifakara Health Institute, Muhimbili University of Health and Allied Sciences

Outcome

Type Measure Description Time frame Safety issue
Other 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 50)
Other Diarrhea Self-reported any diarrhea symptoms during the intervention period During pregnancy (up to week 50)
Other Heartburn Self-reported any heartburn symptoms during the intervention period During pregnancy (up to week 50)
Other Constipation Self-reported any constipation symptoms during the intervention period During pregnancy (up to week 50)
Other Vomiting Self-reported any vomiting symptoms during the intervention period During pregnancy (up to week 50)
Other Nausea Self-reported any nausea symptoms during the intervention period During pregnancy (up to week 50)
Other Leg Cramps Self-reported any leg cramps during the intervention period During pregnancy (up to week 50)
Other Low back/pelvic pain Self-reported any low back/pelvic pain during the intervention period During pregnancy (up to week 50)
Primary Proportion of pregnant women with third-trimester moderate or severe anemia Defined as a hemoglobin concentration <10 g/dL. 3rd trimester (weeks 27-42 of pregnancy)
Secondary Maternal hemoglobin concentration Continuous hemoglobin concentration measured from venous blood by complete blood count 3rd trimester (weeks 27-42 of pregnancy)
Secondary Maternal hemoglobin concentration Continuous hemoglobin concentration measured from venous blood by complete blood count 6 weeks postpartum
Secondary Proportion of pregnant women with anemia Hb concentration < 11 g/dL 3rd trimester (weeks 27-42 of pregnancy)
Secondary Proportion of postpartum women with anemia Hb concentration < 12 g/dL 6 weeks postpartum
Secondary Maternal serum ferritin Inflammation-adjusted serum ferritin 3rd trimester (weeks 27-42 of pregnancy)
Secondary Proportion of pregnant women with iron deficiency Inflammation-adjusted serum ferritin < 15 ug/L 3rd trimester (weeks 27-42 of pregnancy)
Secondary Proportion of pregnant women with iron deficiency anemia Anemia (Hb < 10 g/dL) and iron deficiency (inflammation-adjusted serum ferritin < 15 ug/L) 3rd trimester (weeks 27-42 of pregnancy)
Secondary 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
Secondary 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
Secondary Proportion of women with postpartum hemorrhage Clinical diagnosis of postpartum hemorrhage or use of critical interventions to treat postpartum hemorrhage From 24 weeks gestation through 42 days post delivery
Secondary Proportion of women with peripartum infection 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 and all other incident infections in the peripartum period. During pregnancy through 42 days postpartum
Secondary 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 42 days within termination of pregnancy
Secondary Proportion of women with symptoms consistent with depression Patient Health Questionnaire-9 (PHQ-9) score ranging from 0 to 27, with higher number is consistent with depression and anxiety 3rd trimester (weeks 27-42 of pregnancy)
Secondary Proportion of women with symptoms consistent with depression Patient Health Questionnaire-9 (PHQ-9) score ranging from 0 to 27, with higher number is consistent with depression and anxiety 6 weeks postpartum
Secondary Proportion of women with symptoms consistent with fatigue FACIT assessment score ranging from 0 to 52, with lower number is consistent with having fatigue. 3rd trimester (weeks 27-42 of pregnancy)
Secondary Proportion of women with symptoms consistent with fatigue FACIT assessment score ranging from 0 to 52, with lower number is consistent with having fatigue. 6 weeks postpartum
Secondary Proportion of women with malaria infection Based on HRP2 biomarker and rapid-diagnostic tests (RDTs) Pregnancy through 42 days postpartum
Secondary 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 1-40 of pregnancy)
Secondary Proportion of stillbirths Fetal death = 28 weeks gestation At pregnancy termination (weeks 1-40 of pregnancy)
Secondary Birthweight Continuous birthweight among live births At birth
Secondary Proportion of live births with low birthweight Live birth with birthweight < 2500 g At birth
Secondary 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
Secondary Proportion of preterm live births Live birth <37 weeks gestation (based on best obstetric estimate) At birth
Secondary Birthweight for gestational age Continuous centile based on INTERGROWTH-21st standard birth centile among live births At birth
Secondary 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
Secondary 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
Secondary Infant hemoglobin concentration Continuous Hb concentration measured from capillary blood by complete blood count At 6 weeks of age
Secondary Infant serum ferritin Continuous inflammation adjusted serum ferritin At 6 weeks of age
Secondary Proportion of infants with iron deficiency Inflammation-adjusted serum ferritin < 20 ug/L At 6 weeks of age
Secondary Proportion of neonatal deaths Death of liveborn infant during the first 28 completed days of life From birth to 28 days of age
Secondary 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
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