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

President and Fellows of Harvard College

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Dietary Supplement: Multivitamins-Multiples of RDA; Dietary Supplement: Multivitamins-Single RDA

Study type: Interventional

Funder types: Other

Identifiers

NCT00197678

HD32257-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,141 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,141 participants in 2 patient groups

Multivitamins-Single RDA

Experimental group

Description:

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

Treatment:

Dietary Supplement: Multivitamins-Single RDA

Multivitamins-Multiples of RDA

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Multivitamins-Multiples of RDA