B Cartmel1, T E Moon, N Levine. 1. University of Arizona Cancer Center and the Arizona Health Sciences Center, Tucson, USA. brenda.cartmel@yale.edu
Abstract
BACKGROUND: Chemopreventive agents developed to be used in a moderate-risk but otherwise healthy population need to be both efficacious and to have minimal adverse effects. OBJECTIVE: The objective of this study was to evaluate the adverse effects of long-term retinol intake in a skin cancer chemoprevention trial in a large population at moderate risk for skin cancer. DESIGN:Participants (n = 2297) were randomly assigned to receive retinol [7576 retinol equivalents (RE), or 25000 IU] or a placebo daily. The adverse effects of retinol intake were studied by monitoring 14 clinical symptoms and laboratory indexes. The median follow-up time was 3.8 y. RESULTS: No adverse effects concerning the 14 symptoms were observed. Significant differences in alkaline phosphatase (P < 0.0001), triacylglycerol (P < 0.0001), cholesterol (P = 0.04), and HDL (P = 0.01) were observed over time between the 2 groups. After 49 mo of follow-up, alkaline phosphatase was 7% higher, triacylglycerol was 11% higher, cholesterol was 3% higher, and HDL was 1% lower in the retinol group than in the placebo group. CONCLUSIONS: Because a 1% increase in cholesterol concentrations has been reported to be associated with a 2% increase in coronary artery disease risk, long-term ingestion of 7576 RE vitamin A/d should be considered with caution. However, further studies are needed to confirm this finding.
RCT Entities:
BACKGROUND: Chemopreventive agents developed to be used in a moderate-risk but otherwise healthy population need to be both efficacious and to have minimal adverse effects. OBJECTIVE: The objective of this study was to evaluate the adverse effects of long-term retinol intake in a skin cancer chemoprevention trial in a large population at moderate risk for skin cancer. DESIGN:Participants (n = 2297) were randomly assigned to receive retinol [7576 retinol equivalents (RE), or 25000 IU] or a placebo daily. The adverse effects of retinol intake were studied by monitoring 14 clinical symptoms and laboratory indexes. The median follow-up time was 3.8 y. RESULTS: No adverse effects concerning the 14 symptoms were observed. Significant differences in alkaline phosphatase (P < 0.0001), triacylglycerol (P < 0.0001), cholesterol (P = 0.04), and HDL (P = 0.01) were observed over time between the 2 groups. After 49 mo of follow-up, alkaline phosphatase was 7% higher, triacylglycerol was 11% higher, cholesterol was 3% higher, and HDL was 1% lower in the retinol group than in the placebo group. CONCLUSIONS: Because a 1% increase in cholesterol concentrations has been reported to be associated with a 2% increase in coronary artery disease risk, long-term ingestion of 7576 RE vitamin A/d should be considered with caution. However, further studies are needed to confirm this finding.
Authors: Goran Bjelakovic; Dimitrinka Nikolova; Lise Lotte Gluud; Rosa G Simonetti; Christian Gluud Journal: Cochrane Database Syst Rev Date: 2012-03-14