A broad-spectrum micronutrient supplement can increase CD4 cell counts in patients taking antiretroviral therapy according to a randomised, placebo-controlled trial. The study’s findings were published in the 15th August edition of The Journal of Acquired Immune Deficiency Syndromes, after being presented at a medical conference in 2004.
Although the supplement did not affect HIV viral loads or cause any side-effects or abnormalities in the patients’ blood, it did not cause a significant improvement in the symptoms of peripheral neuropathy.
Studies have found that supplementation with vitamins and minerals can improve the CD4 and CD8 cell counts of patients not taking antiretroviral therapy, decreasing the risk of death in patients with low CD4 cell counts. Now, this small study has shown that a high-dose supplement containing 33 ingredients can also improve the outcomes of anti-HIV treatment. The supplement was developed by Jon Kaiser, a San Francisco-based HIV doctor.
Dr Kaiser and his colleagues recruited 40 patients for the study. All of the participants were taking antiretroviral therapy containing d4T (stavudine, Zerit) or ddI (didanosine, Videx / VidexEC), and had symptoms of peripheral neuropathy, including pain or altered sensations in the extremities. The investigators randomised the patients to receive the supplement twice a day with food, or to receive an identical-looking placebo tablet that contained no vitamins or minerals.
After twelve weeks, the patients taking the micronutrient supplement had a mean CD4 cell count increase of 64.7 cells/mm3, compared to a fall of 5.8 cells/mm3 in the placebo arm. This difference was statistically significant (p = 0.029). This was equivalent to a 24% increase in the supplement group, compared to 0% in the patients taking placebo capsules (p = 0.01).
There was no significant difference between the two groups of patients in change in the HIV viral load (-0.1 vs. 0.1 log10, p = 0.263). In addition, although the symptoms of neuropathy improved in the patients taking the supplement, this was matched by a similar increase in the placebo arm (42 vs. 33%).
There were no differences between groups in blood levels of glucose, insulin and fats, and there were no significant side-effects seen in the patients taking the supplement.
“This investigation is the first trial of micronutrient supplementation to show a significant immunologic benefit in patients taking a stable highly active antiretroviral therapy (HAART) regimen,” the researchers conclude. “Moreover, the robust recuperation of the CD4 cell count in the micronutrient group occurred after twelve weeks of supplementation, a relatively short period of time compared with the slower reconstitution reported by other cohorts after initiating HAART without micronutrient supplementation.”
The investigators suggest that the supplement could improve CD4 cell counts through a number of mechanisms. While some B vitamins and vitamins C and E may enhance the immune system directly, the supplement also contained the antioxidants acetyl L-carnitine, N-acetyl cysteine and alpha lipoic acid. These may reverse the oxidative stress caused by HIV infection, that is responsible for the death of CD4 T-cells, at least in part.
However, the study only enrolled 40 patients and was limited by its short twelve-week duration. It is possible that any improvements in neuropathy may require a larger sample of patients or a longer follow-up period to be detected. In addition, the impact of an increase in CD4 cell count of 63 cells/mm3, on average, from a baseline of 357 cells/mm3 on the patients’ health is unclear until further studies are carried out.
What’s more, the investigators do not explain the reasons for an average decline in CD4 cell counts in the placebo group, and do not give any information on the other anti-HIV drugs the patients were taking, or the total length of time that they had been taking antiretroviral therapy. The patients’ mean viral loads were also incompletely suppressed, with mean viral loads well above the target of 50 copies/ml or less through the study. This raises further questions about the utility of supplementation in patients with fully suppressed viral loads.
The micronutrient supplement used in this study is available commercially, but it is expensive. Although the K-Pax vitamins website claims that the supplement is cheaper than buying the components separately and that it does not include the fillers and binders used in other preparations, a one-month supply of the supplement currently costs £89.95.
Kaiser JD et al. Micronutrient supplementation increases CD4 count in HIV-infected individuals on highly active antiretroviral therapy. J Acquir Immune Defic Syndr 42: 523-528, 2006.