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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197678
• Other study ID #: HD32257-2
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: November 9, 2010
• Start date: November 2002
• Est. completion date: July 2005

Study information

• Verified date: November 2010
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardTanzania: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1141
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Harvard School of Public Health	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	Muhimbili University of Health and Allied Sciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low birthweight (< 2500 g)		Delivery	No
Primary	Pre-term birth (< 36 weeks gestation)		Monthly until the 32nd week of pregnancy, once every 2 weeks from 32nd to 36th week	No