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
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
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
NCT ID
NCT00197548
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
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
Learn more about this trial
A Trial of Micronutrients and Adverse Pregnancy Outcomes
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