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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

November 9, 2010

Start Date ^ICMJE

November 2002

Primary Completion Date

July 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00197678 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Maternal and newborn health outcomes

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Comparison of Two Multivitamin Dosage Regimens in the Prevention of Adverse Pregnancy Outcomes Among HIV-Positive Women From Tanzania

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1141

Completion Date

July 2005

Primary Completion Date

July 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00197678

Other Study ID Numbers ^ICMJE

HD32257-2

Has Data Monitoring Committee

Responsible Party

Wafaie Fawzi MD, DrPH, Harvard School of Public health

Study Sponsor ^ICMJE

Harvard School of Public Health

Collaborators ^ICMJE

Muhimbili University of Health and Allied Sciences

Investigators ^ICMJE

Principal Investigator:

Wafaie W. Fawzi, MD,DrPH

Harvard School of Public Health

Information Provided By

Harvard School of Public Health

Verification Date

November 2010

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

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