Clinical Trial on the Effects of Vitamin D Supplementation on Metabolic Profiles in Diabetic Hemodialysis
Authors: Elahe Seyed Hosseini
Zatollah Asemi
Malihe Zarrati Mojarrad
Fariba Keneshlou
Mohammad Reza Tamadon
Alireza Soleimani
Hamed Haddad Kashani
Fereshteh Bahmani
Afshin Naseri
Journal: Hormone and Metabolic Research (2018)
Discipline: BIOLOGY & BIOCHEMISTRY
Keywords: Vitamin D supplementation; insulin metabolism; lipid fractions; inflammation; oxidative stress
Affiliations: Department of Internal Medicine, School of Medicine, Semnan University of Medical Sciences, Semnan, Iran., Department of Internal Medicine, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran., Department of Urology, School of Medicine, Alborz University of Medical Sciences, Karaj, Iran., Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran., Anatomical Sciences Research Center, Kashan University of Medical Sciences, Kashan, Iran.

Abstract:  The current study was conducted to assess the effects of vitamin D supplementation on insulin metabolism, lipid fractions, biomarkers of inflammation, and oxidative stress in diabetic hemodialysis (HD) patients. This randomized double-blind placebo-controlled clinical trial was carried out among 60 diabetic HD patients. Subjects were randomly allocated into two groups to intake either oral vitamin D3 supplements at a dosage of 50 000 IU (n=30) or placebo (n=30) every 2 weeks for 12 weeks. After 12 weeks of intervention, subjects who received vitamin D supplements compared with the placebo had significantly decreased serum insulin concentrations (-3.4±3.7 vs. +2.0±4.2 μIU/ml, p&lt;0.001), homeostasis model of assessment-estimated insulin resistance (HOMA-IR) (-1.2±1.8 vs. +0.9±2.3, p&lt;0.001), and improved quantitative insulin sensitivity check index (QUICKI) (+0.02±0.03 vs. -0.01±0.02, p&lt;0.001). In addition, compared with the placebo, vitamin D supplementation led to significant reductions in serum high-sensitivity C-reactive protein (hs-CRP) (-1.4±2.5 vs. +1.4±4.8 mg/l, p=0.007), plasma malondialdehyde (MDA) (-0.1±0.2 vs. +0.1±0.2 μmol/l, p=0.009) and a significant increase in plasma total antioxidant capacity (TAC) concentrations (+33.8±56.7 vs. -2.0±74.5 mmol/l, p=0.04). We did not see any significant effect of vitamin D supplementation on lipid profiles and other biomarkers of inflammation and oxidative stress compared with the placebo. Overall, we found that vitamin D supplementation had beneficial effects on serum insulin, HOMA-IR, QUICKI, serum hs-CRP, plasma MDA, and TAC levels among diabetic HD patients for 12 weeks. CLINICAL REGISTRATION:: http://www.irct.ir: IRCT201611155623N92. 

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 A166 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. 18 publications have an expression of concern, and 6 have been retracted. To our knowledge there has been no public response about any of the concerns. We think these publications are unreliable ,