August 16, 2006 (AIDSmeds)—Longtime nutrition advocate Jon Kaiser, MD, and his
colleagues presented data at the XVI International AIDS Conference
regarding 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 more
rigorous 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 destructive
molecules called "free radicals" that can be caused by the use of nucleoside reverse transcriptase inhibitors
(NRTIs) known to damage cellular mitochondria, the DNA powerhouses
inside cells. These free radicals, Dr. Kaiser has explained in the
past, can lead to damage to cells and tissues in the body and
ultimately contributed to more rapid disease progression and treatment
toxicities.
In this clinical trial, conducted at four
centers in the United States, 40 HIV-positive people were randomized to
take a combination of micronutrients or matching placebos in addition
to 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.
The
micronutrient combination used in the study included a daily
multivitamin (containing vitamins A, B, C, D, and E), a daily
multimineral (containing zinc, selenium, calcium, magnesium, and
folate), 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 the
group of 18 patients randomized to the micronutrient combination and
467 in the group of 22 patients randomized to placebo. Patients in the
micronutrient group had been experiencing neuropathy symptoms for an
average of 21.4 months, compared to an average of 12.2 months in the
placebo group.
After 12 weeks in the study, patients
in the micronutrient group saw their CD4 count increase by 65 cells and
their CD4 percentages increase by 24%, compared to a decline of 6 CD4
cells and no increase in CD4 percentages in the placebo group. The
differences between the micronutrient group and placebo group were
statistically 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.
As
for 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 reach
statistical significance.
Dr. Kaiser explained that
micronutrient supplementation was well tolerated. While one patient
experienced bacterial pneumonia in the study and another experienced
bladder stones, these were not believed to be related to micronutrient
supplementation.
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