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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Harvard School of Public Health

Collaborator
Muhimbili University of Health and Allied Sciences

Information provided by (Responsible Party)
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

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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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

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

Primary Outcome Measures

  • Low birthweight (< 2500 g) [ Time Frame: Delivery ]
  • Pre-term birth (< 36 weeks gestation) [ Time Frame: Monthly until the 32nd week of pregnancy, once every 2 weeks from 32nd to 36th week ]

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes 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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

More Information


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  

Keywords provided by Harvard School of Public Health:

HIV
AIDS
Multivitamins
Pregnancy Outcomes
Women
Tanzania
Africa

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.