A recent clinical report noted that vitamin E administration was followed by a dramatic elevation of high-density lipoprotein cholesterol (HDL-C). Since HDL-C is inversely associated with coronary heart disease, we conducted a randomized, double-blind, placebo-controlled clinical trial of vitamin E administration (800 IU/day) for 16 weeks. The subjects were 30 adults aged 30-60 years, with 15 participants in each group. We measured fasting HDL-C, total cholesterol, and triglycerides at baseline and at 8 and 16 weeks. Vitamin E had no effect on HDL-C; the mean changes at 8 and 16 weeks in the placebo group were -0.3 mg/dL and -2.6 mg/dL, and in the vitamin E group -0.4 and -0.9 mg/dL. Aside from a marginal decrease in calculated low-density lipoprotein cholesterol, at 16 weeks there were no significant differences for any of the lipids. These data, in conjunction with other information in the literature, indicate that vitamin E does not alter plasma lipids in normal adults.