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

• Published in: European journal of clinical nutrition Vol. 60; no. 11; pp. 1266 - 1276
• Main Authors: Austin, J, Singhal, N, Voigt, R, Smaill, F, Gill, M.J, Walmsley, S, Salit, I, Gilmour, J, Schlech, W.F. III, Choudhri, S
• Format: Journal Article
• Language: English
• Published: Basingstoke Nature Publishing 01-11-2006; Nature Publishing Group
• Subjects: Acquired immune deficiency syndrome; acquired immunodeficiency syndrome; Acquired Immunodeficiency Syndrome - blood; Acquired Immunodeficiency Syndrome - drug therapy; Acquired Immunodeficiency Syndrome - mortality; Adult; adults; Aged; AIDS; AIDS (Disease); Anti-HIV Agents - therapeutic use; Antioxidants; Beta carotene; Biological and medical sciences; Carotene; Carotenoids; Carotenoids - administration & dosage; Carotenoids - blood; Carotenoids - therapeutic use; CD4 antigen; CD4 Lymphocyte Count; CD4-positive T-lymphocytes; Cell survival; Clinical nutrition; Clinical outcomes; Clinical trials; community nutrition programs; Death; dietary minerals; Dietary Supplements; Disease Progression; Double-Blind Method; Female; Health aspects; Health services; HIV; Human immunodeficiency virus; Human viral diseases; Humans; Immune system; Immunodeficiencies; Immunodeficiencies. Immunoglobulinopathies; Immunodeficiency; Immunopathology; Infectious diseases; Internet; Lymphocytes; Lymphocytes T; Male; Medical sciences; Metabolic diseases; Micronutrients; Micronutrients - administration & dosage; Micronutrients - therapeutic use; Middle Aged; Mortality; Multivariate Analysis; Nutrition; nutrition assessment; nutritional intervention; nutritional status; Patients; Pharmaceutical industry; Phytochemicals; protective effect; randomized clinical trials; Statistical analysis; Survival; Survival Analysis; Trace elements; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Viral Load; Vitamin A; vitamin-mineral supplements; vitamins; β-Carotene; Canada; United States; Human; Immunopathology; Nutrition; Carotene; Retroviridae; Patient; AIDS; Immune deficiency; Lentivirus; Infection; Virus; Micronutrient; Randomization; Treatment; HIV; carotenoids treatment; Viral disease; Clinical trial; micronutrients; Supplementation; Human immunodeficiency virus; Carotenoid; Community
• ISSN: 0954-3007; 1476-5640
• DOI: 10.1038/sj.ejcn.1602447

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 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.