August 16, 2006 (AIDSmeds)—Longtime nutrition advocate Jon Kaiser, MD, and hiscolleagues presented data at the XVI International AIDS Conferenceregarding the effects of micronutrient supplementation on CD4 cell counts(T cell counts). The encouraging results come from a small randomized,placebo-controlled study that should pave the way for even morerigorous supplementation research in clinical trials.

Dr. Kaiser suggested in his oral presentation in Toronto that deficiencies in micronutrients – such as vitamins, minerals, and antioxidants – in HIV-positive people may be linked to more frequent opportunistic infections, a greater risk of certain medication-related side effects,and even more rapid progression to death. Of particular interest to Dr.Kaiser's group is oxidative stress – the accumulation of destructivemolecules called "free radicals" that can be caused by the use of nucleoside reverse transcriptase inhibitors(NRTIs) known to damage cellular mitochondria, the DNA powerhousesinside cells. These free radicals, Dr. Kaiser has explained in thepast, can lead to damage to cells and tissues in the body andultimately contributed to more rapid disease progression and treatmenttoxicities.

In this clinical trial, conducted at fourcenters in the United States, 40 HIV-positive people were randomized totake a combination of micronutrients or matching placebos in additionto their daily HIV drug regimens. All patients enrolled were on Zerit® (stavudine) and/or Videx® (didanosine), two NRTIs that can damage cellular mitochondria. The patients also needed to have symptoms of peripheral neuropathy upon entering the study.

Themicronutrient combination used in the study included a dailymultivitamin (containing vitamins A, B, C, D, and E), a dailymultimineral (containing zinc, selenium, calcium, magnesium, andfolate), and daily antioxidant supplements (400mg alpha-lipoic acid,1,000mg acetyl-L-cysteine, and 1,200mg N-acetyl-cysteine [NAC]).

At the start of the trial, the average CD4 cell count was 357 in thegroup of 18 patients randomized to the micronutrient combination and467 in the group of 22 patients randomized to placebo. Patients in themicronutrient group had been experiencing neuropathy symptoms for anaverage of 21.4 months, compared to an average of 12.2 months in theplacebo group.

After 12 weeks in the study, patientsin the micronutrient group saw their CD4 count increase by 65 cells andtheir CD4 percentages increase by 24%, compared to a decline of 6 CD4cells and no increase in CD4 percentages in the placebo group. Thedifferences between the micronutrient group and placebo group werestatistically significant, meaning that it wasn't likely due to chance.

Slight decreases in total cholesterol, triglycerides, and glucose levels were also reported, but these changes were not statistically significant.

Asfor neuropathy, symptoms improved in both groups. There was a 42%reduction in symptoms in the micronutrient group compared to a 33%reduction in the placebo group, but these data also failed to reachstatistical significance.

Dr. Kaiser explained thatmicronutrient supplementation was well tolerated. While one patientexperienced bacterial pneumonia in the study and another experiencedbladder stones, these were not believed to be related to micronutrientsupplementation.