A community randomized controlled clinical trial of mixed carotenoids and micronutrient supplementation of patients with acquired immunodeficiency syndrome

J. Austin, N. Singhal, R. Voigt, F. Smaill, M. J. Gill, S. Walmsley, I. Salit, J. Gilmour, W. F. Schlech, S. Choudhri, A. Rachlis, J. Cohen, S. Trottier, E. Toma, P. Phillips, P. M. Ford, R. Woods, J. Singer, D. P. Zarowny, D. W. Cameron

Producción científica: Contribución a una revistaArtículorevisión exhaustiva

33 Citas (Scopus)

Resumen

Objective: This clinical trial aims to evaluate if natural mixed carotenoids supplementation can improve the health and survival of acquired immunodeficiency syndrome (AIDS) patients. Design: A placebo-controlled, prospective, randomized, double-blind, multicenter clinical trial. Setting: Community, tertiary care human immunodeficiency virus (HIV) clinics of the Canadian HIV Trials Network (CTN). Participants: Three hundred and thirty-one adults with advanced AIDS on conventional management were recruited during routine clinic visits. Interventions: 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 120000 IU (72mg) of β-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 μmol/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.

Idioma originalEnglish
Páginas (desde-hasta)1266-1276
Número de páginas11
PublicaciónEuropean Journal of Clinical Nutrition
Volumen60
N.º11
DOI
EstadoPublished - nov. 2006
Publicado de forma externa

Nota bibliográfica

Funding Information:
This study was supported by the Canadian HIV Trials Network, Community Research Initiative of Toronto, USANA Health Sciences Inc. and AIDS Program Committee of the Ontario Ministry of Health. DWC received a Career Scientist Award of the Ontario Ministry of Health. The drugs used in this study were kindly provided by USANA Health Sciences Inc., Salt Lake City, Ut, USA.

ASJC Scopus Subject Areas

  • Medicine (miscellaneous)
  • Nutrition and Dietetics

Huella

Profundice en los temas de investigación de 'A community randomized controlled clinical trial of mixed carotenoids and micronutrient supplementation of patients with acquired immunodeficiency syndrome'. En conjunto forman una huella única.

Citar esto