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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
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV Infections
 Dietary Supplement: Multivitamins-Multiples of RDA
Dietary Supplement: Multivitamins-Single RDA
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Two Multivitamin Dosage Regimens in the Prevention of Adverse Pregnancy Outcomes Among HIV-Positive Women From Tanzania

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • 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 ]

Enrollment: 1141
Study Start Date: November 2002
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multivitamins-Single RDA
Multivitamins at doses resembling a single daily Recommended Dietary Allowance (RDA)
 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
Active Comparator: Multivitamins-Multiples of RDA
Multivitamin supplements at multiples of the Recommended Dietary Allowance (RDA)
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197678

Locations
United States, Massachusetts
Harvard School of Public Health
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Harvard School of Public Health
Muhimbili University of Health and Allied Sciences
Investigators
Principal Investigator: Wafaie W. Fawzi, MD,DrPH Harvard School of Public Health
  More Information

Publications:

Responsible Party: Wafaie Fawzi MD, DrPH, Harvard School of Public health
ClinicalTrials.gov Identifier: NCT00197678     History of Changes
Other Study ID Numbers: HD32257-2
Study First Received: September 13, 2005
Last Updated: November 9, 2010
Health Authority: United States: Institutional Review Board
Tanzania: Institutional Review Board

Keywords provided by Harvard School of Public Health:
HIV
AIDS
Multivitamins
Pregnancy Outcomes
 Women
Tanzania
Africa

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 16, 2012