Micronutrient supplementation increases CD4 count in HIV-infected individuals on highly active antiretroviral therapy: a prospective, double-blinded, placebo-controlled trial.
OBJECTIVE
To examine the immunologic, metabolic, and clinical effects of broad spectrum micronutrient supplementation in HIV-infected patients taking highly active antiretroviral therapy (HAART).


METHODS
A prospective, randomized, double-blinded, placebo-controlled trial.


METHODS
Forty HIV-infected patients taking a stavudine and/or didanosine-based HAART regimen 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.


CONCLUSIONS
Micronutrient 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.
Kaiser
Jon D
JD
Department of Medicine, University of California at San Francisco Medical School, 94941, USA. jonkaiser@mac.com
Campa
Adriana M
AM
Ondercin
Joseph P
JP
Leoung
Gifford S
GS
Pless
Richard F
RF
Baum
Marianna K
MK
D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D001786:Blood Glucose; D018791:CD4 Lymphocyte Count; D002493:Central Nervous System Diseases / Q000503:physiopathology; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy* / Q000276:immunology* / Q000821:virology; D006801:Humans; D007328:Insulin / Q000097:blood; D008055:Lipids / Q000097:blood; D008297:Male; D018977:Micronutrients / Q000008:administration & dosage*; D008875:Middle Aged; D010919:Placebos; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood
D001786:Blood Glucose; D007328:Insulin; D008055:Lipids; D018977:Micronutrients; D010919:Placebos; D012367:RNA, Viral