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Multivitamin Dosage Regimens in the Prevention of Adverse Pregnancy Outcomes Among HIV-Positive Women

This study has been completed.
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by:
Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00197678
First received: September 13, 2005
Last updated: November 9, 2010
Last verified: November 2010

September 13, 2005
November 9, 2010
November 2002
July 2005   (final data collection date for primary outcome measure)
  • Low birthweight (< 2500 g) [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Pre-term birth (< 36 weeks gestation) [ Time Frame: Monthly until the 32nd week of pregnancy, once every 2 weeks from 32nd to 36th week ] [ Designated as safety issue: No ]
To examine if the daily administration of multivitamins to HIV+ pregnant women, at doses resembling the RDA decreases the risks of low birth weight and prematurity compared with daily administration of multivitamins at doses above the RDA.
Complete list of historical versions of study NCT00197678 on ClinicalTrials.gov Archive Site
Not Provided
Maternal and newborn health outcomes
Not Provided
Not Provided
 
Multivitamin Dosage Regimens in the Prevention of Adverse Pregnancy Outcomes Among HIV-Positive Women
Comparison of Two Multivitamin Dosage Regimens in the Prevention of Adverse Pregnancy Outcomes Among HIV-Positive Women From Tanzania

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
HIV Infections
  • Dietary Supplement: Multivitamins-Multiples of RDA
    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
  • Dietary Supplement: Multivitamins-Single RDA
    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
  • Experimental: Multivitamins-Single RDA
    Multivitamins at doses resembling a single daily Recommended Dietary Allowance (RDA)
    Intervention: Dietary Supplement: Multivitamins-Single RDA
  • Active Comparator: Multivitamins-Multiples of RDA
    Multivitamin supplements at multiples of the Recommended Dietary Allowance (RDA)
    Intervention: Dietary Supplement: Multivitamins-Multiples of RDA
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. Epub 2009 Nov 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1141
July 2005
July 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

- HIV-positive pregnant women who are between 12 and 27 weeks gestation who intend to stay in Dar es Salaam until delivery.

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00197678
HD32257-2
No
Wafaie Fawzi MD, DrPH, Harvard School of Public health
Harvard School of Public Health
Muhimbili University of Health and Allied Sciences
Principal Investigator: Wafaie W. Fawzi, MD,DrPH Harvard School of Public Health
Harvard School of Public Health
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP