Cited by 446HIV/AIDS Research and InterventionsHIV Research and TreatmentHIV/AIDS drug development and treatment

A Randomized Trial of Multivitamin Supplements and HIV Disease Progression and Mortality

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Fawzi, Wafaie W., Msamanga, Gernard I., Spiegelman, Donna, Wei, Ruilan, Kapiga, Saidi, Villamor, Eduardo, Mwakagile, Davis, Mugusi, Ferdinand +3 more·2004·New England Journal of Medicine

Abstract

BACKGROUND: Results from observational studies suggest that micronutrient status is a determinant of the progression of human immunodeficiency virus (HIV) disease. METHODS: We enrolled 1078 pregnant women infected with HIV in a double-blind, placebo-controlled trial in Dar es Salaam, Tanzania, to examine the effects of daily supplements of vitamin A (preformed vitamin A and beta carotene), multivitamins (vitamins B, C, and E), or both on progression of HIV disease, using survival models. The median follow-up with respect to survival was 71 months (interquartile range, 46 to 80). RESULTS: Of 271 women who received multivitamins, 67 had progression to World Health Organization (WHO) stage 4 disease or died--the primary outcome--as compared with 83 of 267 women who received placebo (24.7 percent vs. 31.1 percent; relative risk, 0.71; 95 percent confidence interval, 0.51 to 0.98; P=0.04). This regimen was also associated with reductions in the relative risk of death related to the acquired immunodeficiency syndrome (0.73; 95 percent confidence interval, 0.51 to 1.04; P=0.09), progression to WHO stage 4 (0.50; 95 percent confidence interval, 0.28 to 0.90; P=0.02), or progression to stage 3 or higher (0.72; 95 percent confidence interval, 0.58 to 0.90; P=0.003). Multivitamins also resulted in significantly higher CD4+ and CD8+ cell counts and significantly lower viral loads. The effects of receiving vitamin A alone were smaller and for the most part not significantly different from those produced by placebo. Adding vitamin A to the multivitamin regimen reduced the benefit with regard to some of the end points examined. CONCLUSIONS: Multivitamin supplements delay the progression of HIV disease and provide an effective, low-cost means of delaying the initiation of antiretroviral therapy in HIV-infected women.

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Research works printed but not linked: 2

  1. World Health Organization. Interim proposal for a WHO staging system for HIV infection and disease. Wkly Epidemiol Rec 1990;65:221-4.
  2. Diggle P, Liang KY, Zeger SL, eds. Analy- sis of longitudinal data. Oxford, England: Oxford University Press, 1995.

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Authors
Fawzi, W. W., Msamanga, G. I., Spiegelman, D., Wei, R., Kapiga, S., Villamor, E., Mwakagile, D., Mugusi, F., Hertzmark, E., Essex, M., & Hunter, D. J.
Affiliations
  • Harvard University (US)
  • Muhimbili University of Health and Allied Sciences (TZ)
Venue
New England Journal of Medicine
Published
2004-07
Volume
351
Issue
1
Pages
23-32
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2128698112
Cited by
446
References
30
Citations by year
2026: 2 · 2025: 3 · 2024: 4 · 2023: 4 · 2022: 5 · 2021: 7 · 2020: 11 · 2019: 11 · 2018: 5 · 2017: 10 · 2016: 15 · 2015: 20 · 2014: 24 · 2013: 32 · 2012: 33
FWCI
26.67
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
  • Digital Access to Scholarship at Harvard (DASH) (Harvard University) (submittedVersion, cc-by)
Funders
U.S. Public Health Service (R0132257)
Topics
  • Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
  • Life Sciences › Immunology and Microbiology › Virology › HIV Research and Treatment
  • Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
Keywords
multivitamins, HIV disease progression, HIV mortality, vitamin A, beta-carotene, micronutrient supplementation, pregnant women, CD4 count, viral load
MeSH terms
Adult, Female, Humans, Pregnancy, Pregnancy Complications, Infectious, Tanzania, Vitamin A, Vitamins, HIV Infections, AIDS-Related Opportunistic Infections, Infectious Disease Transmission, Vertical, Disease Progression, CD4 Lymphocyte Count, Micronutrients, Viral Load, Dietary Supplements

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