Supplementation Increases CD4 Count in HIV-Infected Individuals on Highly
Antiretroviral Therapy: A Prospective, Double-Blinded, Placebo-Controlled Trial.
Journal of Acquired Immune Deficiency Syndromes. 42(5):523-528, August 15, 2006.
Kaiser, Jon D. MD *; Campa, Adriana M. PhD +; Ondercin, Joseph P. PA-C ++;
Leoung, Gifford S. MD [S]; Pless, Richard F. PhD [//]; Baum, Marianna K. PhD dagger;
Objective: To examine the immunologic, metabolic, and clinical effects of broad spectrum micronutrient
supplementation in HIV-infected patients taking highly active antiretroviral therapy (HAART).
Design: A prospective, randomized, double-blinded, placebo-controlled trial.
Methods: Forty HIV-infected patients
taking a stavudine and/or didanosine-based
were prospectively randomized to receive micronutrients or placebo twice daily for 12 weeks. Data were
collected at 4-week intervals including immunologic, metabolic, and clinical measurements. The study
examined the effect of micronutrient supplementation on immunologic parameters as the primary end point.
The secondary end points were metabolic and clinical effects and distal symmetrical polyneuropathy.
Results: The mean absolute CD4 count
increased by an average of 65 cells in the micronutrient group
versus a 6-cell decline in the placebo group at 12 weeks (P = 0.029). The absolute CD4 count increased
by an average of 24% in the micronutrient group versus a 0% change in the placebo group (P = 0.01). The
mean HIV-1 RNA decreased in the micronutrient supplementation group, although not significantly.
Neuropathy scores improved in the micronutrient group by 42% compared with a 33% improvement in the
placebo arm. This difference did not reach statistical significance. Fasting serum glucose, insulin, and lipids
were not adversely affected in the patients taking the micronutrients.
supplementation can significantly improve CD4 cell count reconstitution in
HIV-infected patients taking HAART. The micronutrient supplement tested was well tolerated and may
hold promise as an adjuvant therapy in the treatment of HIV. Further investigation is warranted.