title: A community randomized controlled clinical trial of mixed carotenoids and micronutrient supplementation of patients with acquired immunodeficiency syndrome.
abstract: 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.
authors.affiliation: The Community Research Initiative of Toronto, Toronto, Canada.
authors.forename: J
authors.initials: J
authors.lastname: Austin
authors.forename: N
authors.initials: N
authors.lastname: Singhal
authors.forename: R
authors.initials: R
authors.lastname: Voigt
authors.forename: F
authors.initials: F
authors.lastname: Smaill
authors.forename: M J
authors.initials: MJ
authors.lastname: Gill
authors.forename: S
authors.initials: S
authors.lastname: Walmsley
authors.forename: I
authors.initials: I
authors.lastname: Salit
authors.forename: J
authors.initials: J
authors.lastname: Gilmour
authors.forename: W F
authors.initials: WF
authors.lastname: Schlech
authors.forename: S
authors.initials: S
authors.lastname: Choudhri
authors.forename: A
authors.initials: A
authors.lastname: Rachlis
authors.forename: J
authors.initials: J
authors.lastname: Cohen
authors.forename: S
authors.initials: S
authors.lastname: Trottier
authors.forename: E
authors.initials: E
authors.lastname: Toma
authors.forename: P
authors.initials: P
authors.lastname: Phillips
authors.forename: P M
authors.initials: PM
authors.lastname: Ford
authors.forename: R
authors.initials: R
authors.lastname: Woods
authors.forename: J
authors.initials: J
authors.lastname: Singer
authors.forename: D P
authors.initials: DP
authors.lastname: Zarowny
authors.forename: D W
authors.initials: DW
authors.lastname: Cameron
mesh_terms: 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
chemical_list: D019380:Anti-HIV Agents; D018977:Micronutrients; D002338:Carotenoids