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

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, Tanzania

Eligibility Criteria

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

Inclusion Criteria: Attending first ANC visit at the study clinic Pregnant women ≤ 15 weeks of gestation Aged ≥ 18 years Intending to stay in Dar es Salaam for the duration of study Provides informed consent Exclusion Criteria: Severe anemia (defined as Hb <8.5 g/dL per Tanzania standard of care) Sickle cell disease (homozygous) as tested by HemoTypeSC Concurrent participation in other nutritional supplementation trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    MMS with 30 mg iron first, then MMS with 45 mg of iron, then MMS wit 60 mg of iron

    MMS with 30 mg iron first, then MMS with 60 mg of iron, then MMS with 45 mg of iron

    MMS with 45 mg iron first, then MMS with 30 mg of iron, then MMS with 60 mg of iron

    MMS with 45 mg first, then MMS with 60 mg of iron, then MMS with 45 mg of iron

    MMS with 60 mg of iron first, then MMS with 30 mg of iron, then MMS with 45 mg of iron

    MMS with 60 mg of iron first, then MMS with 45 mg of iron, then MMS with 30 mg of iron

    Arm Description

    Outcomes

    Primary Outcome Measures

    Acceptability of MMS formulations
    To assess acceptability of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using Likert scales
    Preference of MMS formulations
    To assess preference of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using questionnaires
    Side effects of MMS formulations
    To assess perceived side effects of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using questionnaires
    Acceptability of MMS formulations
    To assess acceptability of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using Likert scales
    Preference of MMS formulations
    To assess preference of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using questionnaires
    Side effects of MMS formulations
    To assess perceived side effects of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using questionnaires
    Acceptability of MMS formulations
    To assess acceptability of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using Likert scales
    Preference of MMS formulations
    To assess preference of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using questionnaires
    Side effects of MMS formulations
    To assess perceived side effects of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using questionnaires

    Secondary Outcome Measures

    Full Information

    First Posted
    September 15, 2023
    Last Updated
    September 29, 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
    NCT06069869
    Brief Title
    Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania ( MMS-MAP )- MMS Iron Dose Trial
    Official Title
    Individually 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- MMS Iron Dose Crossover Trial
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    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 a mixed methods cross-over study to assess acceptability, preference, and perceived side effects of MMS formulations with 30 mg, 45 mg and 60 mg of iron. The use of a cross-over design is used in studies examining the acceptability of other nutritional products, including Ready-to-Use Therapeutic Foods.

    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, Tanzania

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Model Description
    Each participant will be randomized to one of 6 sequence orders to receive the three MMS regimens first, second or third in order (e.g., 30, 45, then 60 mg; or 45, 30, then 60 mg; or 45, 60 then 30 mg etc.).
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) 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
    156 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MMS with 30 mg iron first, then MMS with 45 mg of iron, then MMS wit 60 mg of iron
    Arm Type
    Experimental
    Arm Title
    MMS with 30 mg iron first, then MMS with 60 mg of iron, then MMS with 45 mg of iron
    Arm Type
    Experimental
    Arm Title
    MMS with 45 mg iron first, then MMS with 30 mg of iron, then MMS with 60 mg of iron
    Arm Type
    Experimental
    Arm Title
    MMS with 45 mg first, then MMS with 60 mg of iron, then MMS with 45 mg of iron
    Arm Type
    Experimental
    Arm Title
    MMS with 60 mg of iron first, then MMS with 30 mg of iron, then MMS with 45 mg of iron
    Arm Type
    Experimental
    Arm Title
    MMS with 60 mg of iron first, then MMS with 45 mg of iron, then MMS with 30 mg of iron
    Arm Type
    Experimental
    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 to end of study.
    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 to end of study.
    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 to end of study.
    Primary Outcome Measure Information:
    Title
    Acceptability of MMS formulations
    Description
    To assess acceptability of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using Likert scales
    Time Frame
    Month 1
    Title
    Preference of MMS formulations
    Description
    To assess preference of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using questionnaires
    Time Frame
    Month 1
    Title
    Side effects of MMS formulations
    Description
    To assess perceived side effects of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using questionnaires
    Time Frame
    Month 1
    Title
    Acceptability of MMS formulations
    Description
    To assess acceptability of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using Likert scales
    Time Frame
    Month 2
    Title
    Preference of MMS formulations
    Description
    To assess preference of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using questionnaires
    Time Frame
    Month 2
    Title
    Side effects of MMS formulations
    Description
    To assess perceived side effects of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using questionnaires
    Time Frame
    Month 2
    Title
    Acceptability of MMS formulations
    Description
    To assess acceptability of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using Likert scales
    Time Frame
    Month 3
    Title
    Preference of MMS formulations
    Description
    To assess preference of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using questionnaires
    Time Frame
    Month 3
    Title
    Side effects of MMS formulations
    Description
    To assess perceived side effects of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using questionnaires
    Time Frame
    Month 3

    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 the study clinic Pregnant women ≤ 15 weeks of gestation Aged ≥ 18 years Intending to stay in Dar es Salaam for the duration of study Provides informed consent Exclusion Criteria: Severe anemia (defined as Hb <8.5 g/dL per Tanzania standard of care) Sickle cell disease (homozygous) as tested by HemoTypeSC Concurrent participation in other nutritional supplementation 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 George 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 ( MMS-MAP )- MMS Iron Dose Trial

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