Published in JAMA, the new research shows that receiving a high-dose multivitamin supplementation after beginning highly active antiretroviral therapy (HAART) does not reduce the risk of HIV disease progression or death compared to a standard-dose of multivitamins.
In addition to offering no further benefits, the US-based researchers warn that high-dose supplements also may actually cause harm, due to adverse effects such as increased levels of a certain liver enzymes. Such fears of harm led to the full trial to be cut short, the authors note.
"Although the provision of high-dose vitamin supplements has been found safe and efficacious among HIV-infected patients not receiving HAART, the results from this study show that the safety and efficacy of nutritional interventions in the context of potent combination therapies such as HAART need to be further examined," said senior author Professor Wafaie Fawzi of Harvard School of Public Health.
Lead author, Sheila Isanaka, added that the study provides ‘no clear evidence’ of a benefit for high-dose micronutrient supplementation compared to standard-dose supplementation, “but it highlights the need for further research on how micronutrient supplements can be better positioned alongside antiretroviral drugs to reduce morbidity and mortality due to HIV."
Isanaka and her team note that although HAART undoubtedly has major benefits, the recovery of the immune system is incomplete, and the risks of mortality and opportunistic infections remain high especially in the first few months after HAART initiation.
As a result the research team set up the new study to follow a group of 3,418 patients with HIV, all who had recently started HAART, for two years in order to test the effects of supplementation. Half were given high-dose multivitamin supplements including vitamin B complex, vitamin C, and vitamin E; while the other half received standard supplements at the recommended dietary allowance level.
Isanaka and her colleagues reveal that high-dose supplementation had no effect on key measures of HIV disease progression — including CD4 immune cell counts, plasma viral load, body mass index, or hemoglobin level concentration.
In addition the high-dose supplements did not reduce death or disease progression risks for HIV-infected patients compared to the standard supplementation. They reveal that HIV disease progression or death occurred in 1,231 of 1,710 patients (72.0%) in the high-dose group and in 1,229 of 1,708 patients (72.0%) in the standard-dose group.
In fact, the researchers warn that high-dose multivitamins has the potential to cause harm by increasing the risk of elevated levels of alanine transaminase (ALT) – an enzyme associated with liver problems and other serious conditions.
“The incidence of ALT above the upper level of normal was significantly greater among patients in the high-dose supplementation group than the standard-dose supplementation group [1,239 events vs. 879 events],” the authors write.
As a result of this significant increase in ALT risk, the study was stopped early.
Published online ahead of print, doi: 10.1001/jama.2012.13083
“Effect of High-Dose vs Standard-Dose Multivitamin Supplementation at the Initiation of HAART on HIV Disease Progression and Mortality in TanzaniaA Randomized Controlled Trial”
Authors: Sheila Isanaka, Ferdinand Mugusi, Claudia Hawkins, Donna Spiegelman, et al