Effect of Two Different Doses of Vitamin D Supplementation on Metabolic Profiles of Insulin-Resistant Patients with Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial
Authors: Mehri Jamilian
Maesoomeh Talebi
Mansooreh Samimi
Zatollah Asemi
Sahar Mehrabi
Maryam Maktabi
Bita Badehnoosh
Fatemeh Foroozanfard
Journal: Hormone and Metabolic Research (2017)
Discipline: BIOLOGY & BIOCHEMISTRY
Keywords: Vitamin D supplementation; metabolic profiles; insulin-resistant patients; polycystic ovary syndrome (PCOS); randomized double-blind trial
Affiliations: Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, I. R. Iran, Endocrinology and Metabolism Research Center, Arak University of Medical Sciences, Arak, I. R. Iran, Department of Gynecology and Obstetrics, School of Medicine, Alborz University of Medical Sciences, Karaj, I. R. Iran, Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I. R. Iran

Abstract:  The current study was conducted to evaluate the effects of 2 different doses of vitamin D supplementation on metabolic profiles of insulin-resistant patients with polycystic ovary syndrome (PCOS). This randomized double-blind, placebo-controlled trial was performed on 90 insulin-resistant patients with PCOS according to the Rotterdam criteria aged 18-40 years old. Participants were randomly allocated into 3 groups to receive either 4 000 IU of vitamin D (n=30) or 1 000 IU of vitamin D (n=30) or placebo (n=30) per day for 12 weeks. Vitamin D supplementation (4 000 IU), compared with vitamin D (1 000 IU) and placebo, led to reduced fasting plasma glucose (-4.3¬±8.6 vs. -4.7¬±7.1 and +0.1¬±6.7 mg/dl, respectively, p=0.02), serum insulin concentrations (-2.7¬±2.7 vs. -1.4¬±4.2 and -0.1¬±4.1 ŒºIU/ml, respectively, p=0.02), and HOMA-IR (-0.6¬±0.6 vs. -0.4¬±1.0 and -0.1¬±0.9, respectively, p=0.02). In addition, we found significant decreases in mean change of serum triglycerides (-10.3¬±7.3 vs. -3.6¬±14.5 and +6.9¬±23.8 mg/dl, respectively, p=0.001), VLDL- (-2.0¬±1.5 vs. -0.7¬±2.9 and +1.4¬±4.8 mg/dl, respectively, p=0.001), total- (-14.0¬±9.5 vs. -6.2¬±24.0 and +7.1¬±29.7 mg/dl, respectively, p=0.002), LDL- (-10.8¬±8.3 vs. -5.7¬±21.9 and +6.8¬±28.2 mg/dl, respectively, p=0.005), and total-/HDL-cholesterol ratio (-0.2¬±0.3 vs. -0.1¬±0.6 and +0.2¬±0.7 mg/dl, respectively, p=0.003) in the high-dose vitamin D group compared with low-dose vitamin D and placebo groups. Overall, vitamin D supplementation at a dosage of 4 000 IU/day for 12 weeks in insulin-resistant patients with PCOS had beneficial effects of glucose metabolism and lipid profiles compared with 1 000 IU/day of vitamin D and placebo groups. 

Retracted: No

PubPeer comments:
 There are many concerns about the integrity of 172 publications by this research group, including this one. Some of the concerns are published 1. Anaesthesia 2020;75:1683u201392, see Supplementary data. This paper is A88 2. Account Res 2020;28:149-61. 3. J Clin Epidemiol 2021;131:22-29. Journals and publishers were notified of these concerns in July 2019. 23 publications have an expression of concern. To our knowledge there has been no public response about any of the concerns. We think these publications are unreliable ,