Double-Blind Controlled Trial of Vitamin E Effects on Serum Lipid Profile in Menopausal Women

Background: Menopause is associated with changes in lipid profile and is a known risk factor for oxidative stress. Different therapeutical strategies have been used to control menopause complications. Vitamin E, an important anti-oxidant, can possibly affect lipid peroxidation in menopausal women. Thus, we aimed to evaluate the effect of vitamin E supplementation on the lipid profile of menopausal women. Materials and Methods: This double-blind, placebo-controlled, randomized, cross-over, phase I/II trial study was designed in two 4-week intervention phases with an 8-day washout period in between. Eighty-three natural menopause women participated in the study. Randomized block allocation was used to divide women into group A (n = 41) and group B (n = 42). In phase I, one group received vitamin E capsule (400 IU/day) and another group received placebo capsule for 4 weeks. After an 8-day washout period, phase II was initiated for a period of 4 weeks, where the group that received vitamin E capsule was given placebo (E-P) and the group that received placebo was given vitamin E (P-E). Plasma lipid profile levels (LDL-C, HDL-C, TC, and TG) were assessed before and after intervention separately in each phase and in each group. Lipid profile was measured by enzymatic colorimetric method. Data were analyzed according to the intention-to-treat principle. All statistical analyses were performed using SPSS software. Results: The analysis indicated no significant difference in plasma TC, LDL-C, HDL-C, and TG levels between P-E and E-P groups before intervention in phase I and II (P > 0.05). There was no significant difference in plasma lipid profile levels within the P-E and E-P groups before and after intervention in phase I and II. There was a significant difference in plasma TG within the E-P group before [141.74 +/- 53.52, 138.50 (94-195)] and after [167.47 +/- 71.32, 170 (108-202)] intervention in phase II (P = 0.010). There was no significant difference in terms of the mean changes in plasma lipid profile between the P-E and E-P groups in phase I and II (P > 0.05). Conclusion: The study results revealed that vitamin E supplementation had no remarkable effect on the lipid profile in menopausal women.