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

NCT ID: NCT00197678

Last Updated: 2010-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2005-07-31

Brief Summary

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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

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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.

Conditions

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HIV Infections

Keywords

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HIV AIDS Multivitamins Pregnancy Outcomes Women Tanzania Africa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Multivitamins-Single RDA

Multivitamins at doses resembling a single daily Recommended Dietary Allowance (RDA)

Group Type EXPERIMENTAL

Multivitamins-Single RDA

Intervention Type DIETARY_SUPPLEMENT

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

Multivitamins-Multiples of RDA

Multivitamin supplements at multiples of the Recommended Dietary Allowance (RDA)

Group Type ACTIVE_COMPARATOR

Multivitamins-Multiples of RDA

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role lead

Responsible Party

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Harvard School of Public health

Principal Investigators

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Wafaie W. Fawzi, MD,DrPH

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Locations

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Harvard School of Public Health

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 19939985 (View on PubMed)

Other Identifiers

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HD32257-2

Identifier Type: -

Identifier Source: org_study_id