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Multivitamin supplements containing high doses of the vitamin B complex, as well as vitamins C and E, given to HIV-infected women during pregnancy and for more than five years after they gave birth reduced the symptoms of AIDS, according to a study of Tanzanian women supported by the National Institute of Child Health and Human Development (NICHD) and the John E. Fogarty International Center (FIC) for Advanced Study in the Health Sciences, both of the National Institutes of Health. The supplements also bolstered counts of disease-fighting immune cells, and modestly lowered HIV levels in the blood.
The study appears in the July 1, 2004 New England Journal of Medicine.
"This study provides evidence that multivitamin supplements may allow women in developing countries who are infected with the AIDS virus to go for longer than they otherwise would before needing anti-AIDS drugs," said NICHD Director Duane Alexander, MD.
"By keeping women healthier longer, multivitamin therapy can help to assure that anti-HIV drugs can be directed to those who need them most," said FIC Acting Director Sharon Hrynkow, PhD.
The first author of the study was Wafaie Fawzi, associate professor of nutrition and epidemiology at the Harvard School of Public Health. Other authors of the study also were from the Harvard School of Public Health as well as from the Muhimbili University College of Health Sciences in Dar es Salaam, Tanzania.
The authors conducted the study from 1995 to 2003, a time when the antiretroviral drugs were not available to most women in Tanzania, including those who took part in the study.
The researchers enrolled 1,078 HIV-infected pregnant women in Dar es Salaam, Tanzania. Women were assigned to one of four groups and received either a placebo, vitamin A, vitamin A in combination with a multivitamin preparation or a multivitamin preparation alone. The women took the vitamins during pregnancy and continued taking them for as long as they participated in the study more than five years, in many cases. The multivitamin preparation contained high doses of vitamins C, E, and folic acid, as well as the vitamins in the B complex group (B1, B2, B6, B12, and niacin). All of the women received folic acid and an iron supplement during pregnancy, whether they were in the placebo group or the vitamin groups.
All the women received periodic checkups for at least four years after giving birth, and about half of the women received checkups for more than five years after giving birth. The researchers charted the women's progress to determine whether the supplements had an effect on the progression of HIV disease to severe symptoms, to AIDS, or death; or on the levels of certain immune cells (CD4+ and CD8+ cells); and on levels of HIV in the blood.
In all, 18 of 271 (7 percent) of the women who took multivitamins progressed to AIDS during the course of the study, compared with 31 among 267 (12 percent) of the women in the placebo group, a 50 percent reduction in the risk of progression to AIDS. Of the 271, 52 (19 percent) of the women who took multivitamins died, compared with 66 of 267 women (25 percent) in the placebo group. Although the number of deaths were lower in women receiving multivitamins, this was not a statistically significant difference. The effect of multivitamins was strongest in the first two years of follow-up.
The women taking multivitamins also had fewer symptoms of later stage HIV infection, such as mouth infections, mouth ulcers, or diarrheal diseases, than did women in the other group. Similarly, the women in the multivitamin group also had significantly higher CD4+ cell counts than did women in the other groups: overall, the average CD4+ cell count was 48 cells higher in women who received multivitamins compared to those who received placebo. The HIV virus level in the blood was also modestly but significantly lower in women who received multivitamins.
The women who took vitamin A alone did not show any pronounced differences from the women in the placebo group, and adding vitamin A to the multivitamin preparation did not appear to offer any significant added benefit compared with multivitamins alone.
The benefits noted in the Tanzania trial are modest compared to the effects of combination antiretroviral therapy, the authors wrote. In the United States, physicians routinely prescribe multivitamins to pregnant women. Moreover, in developed countries like the United States, pregnant women infected with HIV are routinely given a combination of three or more anti-HIV drugs during pregnancy to prevent the spread of the virus to their infants.
However, in developing countries, vitamin supplementation during pregnancy is not routine and is not provided following pregnancy, explained Lynne Mofenson, MD, chief of NICHD's Pediatric, Adolescent and Maternal AIDS branch, which provided funding for the study.
"These results suggest that use of multivitamins by HIV-infected women during and after pregnancy can slow the course of HIV disease, and could provide a low-cost treatment to prolong the time before they need antiretroviral therapy," Mofenson said. She added that multivitamin therapy could result in significant cost savings for developing countries.
The researchers wrote that the retail costs of a year's supply of the multivitamins used in this trial is about $15, and that wholesale prices are substantially lower. "Our findings should encourage the use of multivitamin supplements as supportive care to those infected with HIV in developing countries," Fawzi said.
Mofenson noted that more studies are needed to define the minimum dose of multivitamins needed to produce a health benefit and to determine whether the multivitamins might provide similar benefits if given to persons already receiving antiretroviral therapy.