A community randomized controlled clinical trial of mixed carotenoids and micronutrient supplementation of patients with acquired immunodeficiency syndrome.
OBJECTIVE
This clinical trial aims to evaluate if natural mixed carotenoids supplementation can improve the health and survival of acquired immunodeficiency syndrome (AIDS) patients.


METHODS
A placebo-controlled, prospective, randomized, double-blind, multicenter clinical trial.


METHODS
Community, tertiary care human immunodeficiency virus (HIV) clinics of the Canadian HIV Trials Network (CTN).


METHODS
Three hundred and thirty-one adults with advanced AIDS on conventional management were recruited during routine clinic visits.


METHODS
All participants, including 166 controls, received daily oral specially formulated multivitamins including vitamin A and trace elements; 165 treatment group participants received additional daily oral natural mixed carotenoids, equivalent to 120,000 IU (72 mg) of beta-carotene daily. Follow-up was quarterly at routine clinic visits.


RESULTS
Mean (s.d.) follow-up was for 13 (6) months. Thirty-six participants died by 18 months. Serum carotene concentration <1.0 micromol/l was present in 16% participants at baseline. Despite variation in carotene content of the treatment medication, serum carotene concentrations increased significantly to twice the baseline levels to 18 months follow-up in participants who received carotenoids treatment compared with controls (P < 0.0001). Although not statistically significant, mortality was increased in participants who did not receive carotenoids treatment compared with those who did (HR time to death 1.76, 95% CI 0.89, 3.47, P = 0.11). In multivariate analysis, survival was significantly and independently improved in those with higher baseline serum carotene concentrations (P = 0.04) or higher baseline CD4 T-lymphocyte counts (P = 0.005). Adjusted mortality was also significantly and independently increased in those who did not receive carotenoids treatment compared with those who did (HR time to death 3.15, 95% CI 1.10, 8.98, P = 0.03).


CONCLUSIONS
Low serum carotene concentration is common in AIDS patients and predicts death. Supplementation with micronutrients and natural mixed carotenoids may improve survival by correction of a micronutrient deficiency. Further studies are needed to corroborate findings and elucidate mechanism of action.
Austin
J
J
The Community Research Initiative of Toronto, Toronto, Canada.
Singhal
N
N
Voigt
R
R
Smaill
F
F
Gill
M J
MJ
Walmsley
S
S
Salit
I
I
Gilmour
J
J
Schlech
W F
WF
Choudhri
S
S
Rachlis
A
A
Cohen
J
J
Trottier
S
S
Toma
E
E
Phillips
P
P
Ford
P M
PM
Woods
R
R
Singer
J
J
Zarowny
D P
DP
Cameron
D W
DW
D000163:Acquired Immunodeficiency Syndrome / Q000097:blood* / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D002338:Carotenoids / Q000008:administration & dosage / Q000097:blood* / Q000627:therapeutic use*; D019587:Dietary Supplements; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D018977:Micronutrients / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D015999:Multivariate Analysis; D016019:Survival Analysis; D019562:Viral Load
D019380:Anti-HIV Agents; D018977:Micronutrients; D002338:Carotenoids