Double-Blind Controlled Trial of Vitamin E Effects on Serum Lipid Profile in Menopausal Women
Authors Rezasoltani P, Elliyoun N, Ziaie T, Sobhani A, Kazemnezhjad Leyli E, Kazemi Aski S
Received 1 October 2019
Accepted for publication 16 September 2020
Published 9 March 2021 Volume 2021:14 Pages 1053—1060
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Prof. Dr. Juei-Tang Cheng
Parvaneh Rezasoltani,1 Nahid Elliyoun,1 Tahereh Ziaie,2 Abdolrasoul Sobhani,3 Ehsan Kazemnezhjad Leyli,4 Soudabeh Kazemi Aski5
1Department of Midwifery, Social Determinants of Health Research Center, School of Nursing and Midwifery, Guilan University of Medical Sciences, Rasht, Iran; 2Department of Midwifery, School of Nursing and Midwifery, Guilan University of Medical Sciences, Rasht, Iran; 3Department of Pharmacology, Gastrointestinal and Liver Diseases Research Center, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran; 4Department of Biostatistics, Road Trauma Research Center, School of Nursing and Midwifery, Guilan University of Medical Sciences, Rasht, Iran; 5Department of Obstetrics & Gynecology, Reproductive Health Research Center, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran
Correspondence: Parvaneh Rezasoltani
Department of Midwifery, School of Nursing & Midwifery, Guilan University of Medical Sciences, Daneshjou Street, Shahid Beheshti Boulevared, Rasht, Guilan Province, 41469-39841, Iran
Tel +98 13 33555058
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Email [email protected]
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.
Keywords: vitamin E, lipid profile, menopausal women
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