Back to resultsMultivitamin Dosage Regimens in the Prevention of Adverse Pregnancy Outcomes Among HIV-Positive Women
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Multivitamins-Multiples of RDA
Multivitamins-Single RDA
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV, AIDS, Multivitamins, Pregnancy Outcomes, Women, Tanzania, Africa
Eligibility Criteria
Inclusion Criteria: - HIV-positive pregnant women who are between 12 and 27 weeks gestation who intend to stay in Dar es Salaam until delivery.
Sites / Locations
- Harvard School of Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multivitamins-Single RDA
Multivitamins-Multiples of RDA
Arm Description
Multivitamins at doses resembling a single daily Recommended Dietary Allowance (RDA)
Multivitamin supplements at multiples of the Recommended Dietary Allowance (RDA)
Outcomes
Primary Outcome Measures
Low birthweight (< 2500 g)
Pre-term birth (< 36 weeks gestation)
Secondary Outcome Measures
Full Information
NCT ID
NCT00197678
First Posted
September 13, 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
NCT00197678
Brief Title
Multivitamin Dosage Regimens in the Prevention of Adverse Pregnancy Outcomes Among HIV-Positive Women
Official Title
Comparison of Two Multivitamin Dosage Regimens in the Prevention of Adverse Pregnancy Outcomes Among HIV-Positive Women From Tanzania
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (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
No
5. Study Description
Brief Summary
The purpose of this study is to examine effects of daily administration of multivitamin supplements at doses resembling the Recommended Dietary Allowance (RDA) during pregnancy to HIV positive women decreases the risks of low birth weight (<2500 g), and pre-term birth (< 37 weeks gestation), compared to multivitamin supplements at doses above the RDA.
Detailed Description
This is a randomized clinical trial conducted to examine effects of daily administration of multivitamin supplements at doses resembling the Recommended Dietary Allowance (RDA) during pregnancy to HIV positive women decreases the risks of low birth weight (<2500 g), and pre-term birth (< 37 weeks gestation), compared to multivitamin supplements at doses above the RDA. All women receive standard prenatal care, including nevirapine for the prevention of mother-to-child transmission of HIV.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, AIDS, Multivitamins, Pregnancy Outcomes, Women, Tanzania, Africa
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1141 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multivitamins-Single RDA
Arm Type
Experimental
Arm Description
Multivitamins at doses resembling a single daily Recommended Dietary Allowance (RDA)
Arm Title
Multivitamins-Multiples of RDA
Arm Type
Active Comparator
Arm Description
Multivitamin supplements at multiples of the Recommended Dietary Allowance (RDA)
Intervention Type
Dietary Supplement
Intervention Name(s)
Multivitamins-Multiples of RDA
Intervention Description
20 mg B1, 20 mg B2, 25 mg B6, 50 mcg B12, 100 mg niacin, 500 mg C, 30 mg E, 0.8 mg folic acid taken orally once per day until 6 weeks after delivery
Intervention Type
Dietary Supplement
Intervention Name(s)
Multivitamins-Single RDA
Intervention Description
1.4 mg B1, 1.4 mg B2, 1.9 mg B6, 50 mcg B12, 100 mg niacin, 70 mg C, 10 mg E, and 0.4 mg folic acid taken orally once per day until 6 weeks after delivery
Primary Outcome Measure Information:
Title
Low birthweight (< 2500 g)
Time Frame
Delivery
Title
Pre-term birth (< 36 weeks gestation)
Time Frame
Monthly until the 32nd week of pregnancy, once every 2 weeks from 32nd to 36th week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- HIV-positive pregnant women who are between 12 and 27 weeks gestation who intend to stay in Dar es Salaam until delivery.
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
Facility Information:
Facility Name
Harvard School of Public Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19939985
Citation
Kawai K, Kupka R, Mugusi F, Aboud S, Okuma J, Villamor E, Spiegelman D, Fawzi WW. A randomized trial to determine the optimal dosage of multivitamin supplements to reduce adverse pregnancy outcomes among HIV-infected women in Tanzania. Am J Clin Nutr. 2010 Feb;91(2):391-7. doi: 10.3945/ajcn.2009.28483. Epub 2009 Nov 25.
Results Reference
result
Learn more about this trial
Multivitamin Dosage Regimens in the Prevention of Adverse Pregnancy Outcomes Among HIV-Positive Women
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