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A Trial of Micronutrients and Adverse Pregnancy Outcomes

Primary Purpose

Pregnancy, Premature Birth, Infant, Low Birth Weight

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Multivitamins-vitamins B-complex, C, and E
Placebo
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring Women, Pregnancy Outcomes, Nutrition, Vitamins, Tanzania, Maternal and Child Health Outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: HIV negative 12-26 weeks gestational age at screening visit

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Multivitamins

    Placebo

    Arm Description

    Multivitamins-vitamins B-complex, C, and E

    Placebo pill

    Outcomes

    Primary Outcome Measures

    Fetal loss, low birth weight and pre-term birth.

    Secondary Outcome Measures

    Child morbidity and mortality; child growth

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    November 9, 2010
    Sponsor
    Harvard School of Public Health (HSPH)
    Collaborators
    Muhimbili University of Health and Allied Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00197548
    Brief Title
    A Trial of Micronutrients and Adverse Pregnancy Outcomes
    Official Title
    A Trial of Micronutrients and Adverse Pregnancy Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2001 (undefined)
    Primary Completion Date
    December 2004 (Actual)
    Study Completion Date
    July 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Harvard School of Public Health (HSPH)
    Collaborators
    Muhimbili University of Health and Allied Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women.
    Detailed Description
    Fetal loss, low birth weight and preterm birth are major public health problems worldwide, particularly in developing countries. Birth outcomes are also major predictors of child health and survival in infancy and beyond. The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women. We also aim to determine whether the potentially protective effect of multivitamin supplements on the risks of low birth weight and preterm birth translate into a sustained reduction in infant mortality.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pregnancy, Premature Birth, Infant, Low Birth Weight, Pregnancy Outcomes
    Keywords
    Women, Pregnancy Outcomes, Nutrition, Vitamins, Tanzania, Maternal and Child Health Outcomes

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    8468 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Multivitamins
    Arm Type
    Active Comparator
    Arm Description
    Multivitamins-vitamins B-complex, C, and E
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo pill
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Multivitamins-vitamins B-complex, C, and E
    Intervention Description
    One daily oral dose of 20 mg of B1, 20 mg of B2, 25 mg of B6, 100 mg of niacin, 50 mcg of B12, 500 mg of C, and 30 mg of vitamin E from randomization until delivery. Participants may continue taking this intervention until 18 months post-partum if they are re-randomized to it after delivery.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    One daily oral dose of a placebo pill taken from randomization until delivery. Participants may continue taking this intervention until 18 months post-partum if they are re-randomized to it after delivery.
    Primary Outcome Measure Information:
    Title
    Fetal loss, low birth weight and pre-term birth.
    Time Frame
    Delivery
    Secondary Outcome Measure Information:
    Title
    Child morbidity and mortality; child growth
    Time Frame
    12 months postpartum

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: HIV negative 12-26 weeks gestational age at screening visit
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wafaie W Fawzi, MD,DrPh
    Organizational Affiliation
    Harvard School of Public Health (HSPH)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17409323
    Citation
    Fawzi WW, Msamanga GI, Urassa W, Hertzmark E, Petraro P, Willett WC, Spiegelman D. Vitamins and perinatal outcomes among HIV-negative women in Tanzania. N Engl J Med. 2007 Apr 5;356(14):1423-31. doi: 10.1056/NEJMoa064868.
    Results Reference
    result
    PubMed Identifier
    35981782
    Citation
    Kamenju P, Madzorera I, Hertzmark E, Urassa W, Fawzi WW. Higher Dietary Intake of Animal Protein Foods in Pregnancy is Associated with Lower Risk of Adverse Birth Outcomes. J Nutr. 2022 Aug 18;152(11):2546-54. doi: 10.1093/jn/nxac183. Online ahead of print.
    Results Reference
    derived
    PubMed Identifier
    34964890
    Citation
    Liu E, Wang D, Darling AM, Perumal N, Wang M, Urassa W, Pembe A, Fawzi WW. Multivitamin Supplementation Is Associated with Greater Adequacy of Gestational Weight Gain among Pregnant Women in Tanzania. J Nutr. 2022 Apr 1;152(4):1091-1098. doi: 10.1093/jn/nxab448.
    Results Reference
    derived
    PubMed Identifier
    32651998
    Citation
    Madzorera I, Isanaka S, Wang M, Msamanga GI, Urassa W, Hertzmark E, Duggan C, Fawzi WW. Maternal dietary diversity and dietary quality scores in relation to adverse birth outcomes in Tanzanian women. Am J Clin Nutr. 2020 Sep 1;112(3):695-706. doi: 10.1093/ajcn/nqaa172.
    Results Reference
    derived
    PubMed Identifier
    31605616
    Citation
    Quinn MK, Smith ER, Williams PL, Urassa W, Shi J, Msamanga G, Fawzi WW, Sudfeld CR. The Effect of Maternal Multiple Micronutrient Supplementation on Female Early Infant Mortality Is Fully Mediated by Increased Gestation Duration and Intrauterine Growth. J Nutr. 2020 Feb 1;150(2):356-363. doi: 10.1093/jn/nxz246.
    Results Reference
    derived
    PubMed Identifier
    29472265
    Citation
    Winje BA, Kvestad I, Krishnamachari S, Manji K, Taneja S, Bellinger DC, Bhandari N, Bisht S, Darling AM, Duggan CP, Fawzi W, Hysing M, Kumar T, Kurpad AV, Sudfeld CR, Svensen E, Thomas S, Strand TA. Does early vitamin B12 supplementation improve neurodevelopment and cognitive function in childhood and into school age: a study protocol for extended follow-ups from randomised controlled trials in India and Tanzania. BMJ Open. 2018 Feb 22;8(2):e018962. doi: 10.1136/bmjopen-2017-018962.
    Results Reference
    derived

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    A Trial of Micronutrients and Adverse Pregnancy Outcomes

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