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

Study Overview
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Dietary Supplement: Multivitamins-Multiples of RDA
* Dietary Supplement: Multivitamins-Single RDA


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multivitamins-Single RDA<br>Multivitamins at doses resembling a single daily Recommended Dietary Allowance (RDA) | Dietary Supplement: Multivitamins-Single RDA<br>* 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<br>|
| Active Comparator: Multivitamins-Multiples of RDA<br>Multivitamin supplements at multiples of the Recommended Dietary Allowance (RDA) | Dietary Supplement: Multivitamins-Multiples of RDA<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, AIDS, Multivitamins, Pregnancy Outcomes, Women, Tanzania, Africa