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Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania (MMS-MAP)

Primary Purpose

Pregnancy Related

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Multiple Micronutrient Supplements with 30 mg of elemental iron
Multiple Micronutrient Supplements with 45 mg of elemental iron
Multiple Micronutrient Supplements with 60 mg of elemental iron
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy Related focused on measuring Pregnancy, Multiple Micronutrient Supplementation, Iron, Anemia, Tanzania

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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 Concurrently enrolled in another nutritional clinical trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    MMS with 30 mg iron

    MMS with 45 mg iron

    MMS with 60 mg iron

    Arm Description

    MMS with standard UNIMMAP formulation of 15 micronutrients, including 30 mg of iron

    MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients

    MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients

    Outcomes

    Primary Outcome Measures

    Proportion of pregnant women with third-trimester moderate or severe anemia
    Defined as a hemoglobin concentration <10 g/dL.

    Secondary Outcome Measures

    Maternal hemoglobin concentration
    Continuous hemoglobin concentration measured from venous blood by complete blood count
    Maternal hemoglobin concentration
    Continuous hemoglobin concentration measured from venous blood by complete blood count
    Proportion of pregnant women with anemia
    Hb concentration < 11 g/dL
    Proportion of postpartum women with anemia
    Hb concentration < 12 g/dL
    Maternal serum ferritin
    Continuous Inflammation-adjusted serum ferritin
    Proportion of pregnant women with iron deficiency
    Inflammation-adjusted serum ferritin < 15 ug/L
    Proportion of pregnant women with iron deficiency anemia
    Anemia (Hb < 10 g/dL) and iron deficiency (inflammation-adjusted serum ferritin < 15 ug/L)
    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
    Proportion of women with antepartum bleeding
    Self-reported or clinical diagnosis of bleeding from or into the genital tract
    Proportion of women with postpartum hemorrhage
    Clinical diagnosis of postpartum hemorrhage or use of critical interventions to treat postpartum hemorrhage
    Proportion of women with peripartum infection
    Infection in the peripartum period
    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
    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
    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
    Proportion of women with malaria infection
    Based on HRP2 biomarker and rapid-diagnostic tests (RDTs)
    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
    Proportion of stillbirths
    Fetal death ≥ 28 weeks gestation
    Birthweight
    Continuous birthweight among live births
    Proportion of live birth with low birthweight
    Live birth with birthweight < 2500 g
    Gestational age at birth
    Duration of gestation in weeks as a continuous measure among live births based on best obstetric estimate among live births
    Proportion of preterm live births
    Live birth <37 weeks gestation (based on best obstetric estimate)
    Birthweight for gestational age
    Continuous centile based on INTERGROWTH-21st standard birth centile among live births
    Proportion of small-for-gestational age live births (<10th percentile)
    Size-for-gestational age <10th on the INTERGROWTH-21st standard among live births
    Proportion of small-for-gestational age live births (<3rd percentile)
    Size-for-gestational age <3rd percentile on the INTERGROWTH-21st standard among live births
    Infant hemoglobin concentration
    Continuous Hb concentration measured from capillary blood by complete blood count
    Infant serum ferritin
    Continuous inflammation adjusted serum ferritin
    Proportion of neonatal deaths
    Death of liveborn infant during the first 28 completed days of life
    Proportion of infant deaths < 42 days
    Death of a live born infant during the first 42 completed days of life

    Full Information

    First Posted
    July 25, 2023
    Last Updated
    October 6, 2023
    Sponsor
    George Washington University
    Collaborators
    Ifakara Health Institute, Harvard School of Public Health (HSPH), Muhimbili University of Health and Allied Sciences, Africa Academy for Public Health, Columbia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06079918
    Brief Title
    Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania
    Acronym
    MMS-MAP
    Official Title
    Randomized Trial of Higher-dose Iron (60 mg, 45 mg) Compared to Low-dose Iron (30 mg) in Multiple Micronutrient Supplements in Pregnancy on Moderate and Severe Maternal Anemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    June 2025 (Anticipated)
    Study Completion Date
    September 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    George Washington University
    Collaborators
    Ifakara Health Institute, Harvard School of Public Health (HSPH), Muhimbili University of Health and Allied Sciences, Africa Academy for Public Health, Columbia University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pregnancy Related
    Keywords
    Pregnancy, Multiple Micronutrient Supplementation, Iron, Anemia, Tanzania

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    6381 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MMS with 30 mg iron
    Arm Type
    Active Comparator
    Arm Description
    MMS with standard UNIMMAP formulation of 15 micronutrients, including 30 mg of iron
    Arm Title
    MMS with 45 mg iron
    Arm Type
    Experimental
    Arm Description
    MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients
    Arm Title
    MMS with 60 mg iron
    Arm Type
    Experimental
    Arm Description
    MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Multiple Micronutrient Supplements with 30 mg of elemental iron
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Multiple Micronutrient Supplements with 45 mg of elemental iron
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Multiple Micronutrient Supplements with 60 mg of elemental iron
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Proportion of pregnant women with third-trimester moderate or severe anemia
    Description
    Defined as a hemoglobin concentration <10 g/dL.
    Time Frame
    3rd trimester (weeks 27-42 of pregnancy)
    Secondary Outcome Measure Information:
    Title
    Maternal hemoglobin concentration
    Description
    Continuous hemoglobin concentration measured from venous blood by complete blood count
    Time Frame
    3rd trimester (weeks 27-42 of pregnancy)
    Title
    Maternal hemoglobin concentration
    Description
    Continuous hemoglobin concentration measured from venous blood by complete blood count
    Time Frame
    6 weeks postpartum
    Title
    Proportion of pregnant women with anemia
    Description
    Hb concentration < 11 g/dL
    Time Frame
    3rd trimester (weeks 27-42 of pregnancy)
    Title
    Proportion of postpartum women with anemia
    Description
    Hb concentration < 12 g/dL
    Time Frame
    6 weeks postpartum
    Title
    Maternal serum ferritin
    Description
    Continuous Inflammation-adjusted serum ferritin
    Time Frame
    3rd trimester (weeks 27-42 of pregnancy)
    Title
    Proportion of pregnant women with iron deficiency
    Description
    Inflammation-adjusted serum ferritin < 15 ug/L
    Time Frame
    3rd trimester (weeks 27-42 of pregnancy)
    Title
    Proportion of pregnant women with iron deficiency anemia
    Description
    Anemia (Hb < 10 g/dL) and iron deficiency (inflammation-adjusted serum ferritin < 15 ug/L)
    Time Frame
    3rd trimester (weeks 27-42 of pregnancy)
    Title
    Proportion of women with preeclampsia
    Description
    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 42 days post delivery
    Title
    Proportion of women with antepartum bleeding
    Description
    Self-reported or clinical diagnosis of bleeding from or into the genital tract
    Time Frame
    From 24 weeks gestation through delivery
    Title
    Proportion of women with postpartum hemorrhage
    Description
    Clinical diagnosis of postpartum hemorrhage or use of critical interventions to treat postpartum hemorrhage
    Time Frame
    From 24 weeks gestation through 42 days post delivery
    Title
    Proportion of women with peripartum infection
    Description
    Infection in the peripartum period
    Time Frame
    During pregnancy through 42 days postpartum
    Title
    Proportion of women with pregnancy-related death
    Description
    Death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the cause of death
    Time Frame
    During pregnancy through 42 days after pregnancy end
    Title
    Proportion of women with symptoms consistent with depression
    Description
    Patient Health Questionnaire-9 (PHQ-9) score ranging from 0 to 27, with higher number is consistent with depression and anxiety
    Time Frame
    3rd trimester (weeks 27-42 of pregnancy)
    Title
    Proportion of women with symptoms consistent with depression
    Description
    Patient Health Questionnaire-9 (PHQ-9) score ranging from 0 to 27, with higher number is consistent with depression and anxiety
    Time Frame
    6 weeks postpartum
    Title
    Proportion of women with malaria infection
    Description
    Based on HRP2 biomarker and rapid-diagnostic tests (RDTs)
    Time Frame
    Pregnancy through 42 days postpartum
    Title
    Proportion of fetal deaths
    Description
    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 1-40 of pregnancy)
    Title
    Proportion of stillbirths
    Description
    Fetal death ≥ 28 weeks gestation
    Time Frame
    At pregnancy termination (weeks 1-40 of pregnancy)
    Title
    Birthweight
    Description
    Continuous birthweight among live births
    Time Frame
    At birth
    Title
    Proportion of live birth with low birthweight
    Description
    Live birth with birthweight < 2500 g
    Time Frame
    At birth
    Title
    Gestational age at birth
    Description
    Duration of gestation in weeks as a continuous measure among live births based on best obstetric estimate among live births
    Time Frame
    At birth
    Title
    Proportion of preterm live births
    Description
    Live birth <37 weeks gestation (based on best obstetric estimate)
    Time Frame
    At birth
    Title
    Birthweight for gestational age
    Description
    Continuous centile based on INTERGROWTH-21st standard birth centile among live births
    Time Frame
    At birth
    Title
    Proportion of small-for-gestational age live births (<10th percentile)
    Description
    Size-for-gestational age <10th on the INTERGROWTH-21st standard among live births
    Time Frame
    At birth
    Title
    Proportion of small-for-gestational age live births (<3rd percentile)
    Description
    Size-for-gestational age <3rd percentile on the INTERGROWTH-21st standard among live births
    Time Frame
    At birth
    Title
    Infant hemoglobin concentration
    Description
    Continuous Hb concentration measured from capillary blood by complete blood count
    Time Frame
    At 6 weeks of age
    Title
    Infant serum ferritin
    Description
    Continuous inflammation adjusted serum ferritin
    Time Frame
    At 6 weeks of age
    Title
    Proportion of neonatal deaths
    Description
    Death of liveborn infant during the first 28 completed days of life
    Time Frame
    From birth to 28 days of age
    Title
    Proportion of infant deaths < 42 days
    Description
    Death of a live born infant during the first 42 completed days of life
    Time Frame
    From birth to 42 days of age

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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 Concurrently enrolled in another nutritional clinical trial
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emily R Smith, ScD, MPH
    Phone
    +1 2029943589
    Email
    emilysmith@gwu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christopher R Sudfeld, ScD, ScM
    Email
    csudfeld@hsph.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Blair Wylie, MD, MPH
    Organizational Affiliation
    Columbia University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Honorati Masanja, PhD
    Organizational Affiliation
    Ifakara Health Institute
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Alfa Muhihi, PhD
    Organizational Affiliation
    Africa Academy for Public Health
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Andreas Pembe, MD, MMed, PhD, FCOG
    Organizational Affiliation
    Muhimbili University of Health and Allied Sciences
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Emily R Smith, ScD, MPH
    Organizational Affiliation
    The Goerge Washington University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Christopher R Sudfeld, ScD, ScM
    Organizational Affiliation
    Harvard University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania

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