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

• Published in: European journal of clinical nutrition 2006-11, Vol.60 (11), p.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: Article
• Language: English
• 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; Epidemiology; Female; Health aspects; Health services; HIV; Human immunodeficiency virus; Human viral diseases; Humans; Immune system; Immunodeficiencies; Immunodeficiencies. Immunoglobulinopathies; Immunodeficiency; Immunopathology; Infectious diseases; Internal Medicine; Internet; Lymphocytes; Lymphocytes T; Male; Medical sciences; Medicine; Medicine & Public Health; Metabolic Diseases; Micronutrients; Micronutrients - administration & dosage; Micronutrients - therapeutic use; Middle Aged; Mortality; Multivariate Analysis; Nutrition; nutrition assessment; nutritional intervention; nutritional status; original-article; Patients; Pharmaceutical industry; Phytochemicals; protective effect; Public Health; 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
• 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