The effects of vitamin D supplementation on wound healing and metabolic status in patients with diabetic foot ulcer: A randomized, double-blind, placebo-controlled trial
Authors: Zahra Soleimani
Reza Razzaghi
Zatollah Asemi
Fereshteh Bahmani
Mansooreh Momen-Heravi
Jafar Shadi
Hamideh Pourbagheri
Journal: Journal of Diabetes and its Complications (2017)
Discipline: CLINICAL MEDICINE
Keywords: Diabetic foot; Inflammation; Insulin resistance; Vitamin D supplementation; Wound healing.
Affiliations: Department of Infectious Disease, School of Medicine, Kashan University of Medical Sciences, Kashan, I.R. Iran., Department of Infectious Disease, School of Medicine, Kashan University of Medical Sciences, Kashan, I.R. Iran; Social Determinants of Health Research Center, Kashan University of Medical Sciences, Kashan, I.R. Iran., Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran., Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran. Electronic address: .

Abstract:  Objective: This study was conducted to evaluate the effects of vitamin D supplementation on wound healing and metabolic status in patients with diabetic foot ulcer (DFU). Methods: This randomized, double-blind, placebo-controlled trial was performed among 60 patients with grade 3 DFU according to "Wagner-Meggitt's" criteria. Participants were randomly divided into two groups (each 30 participants) and received either 50,000IU vitamin D supplements every 2weeks for 12weeks (group A) or placebo (group B). Fasting blood samples were taken at study baseline and after 12-week intervention to determine related markers. Results: After 12weeks of intervention, compared with the placebo, vitamin D supplementation resulted in a significant reduction in ulcer length (-2.1±1.1 vs. -1.1±1.1cm, P=0.001), width (-2.0±1.2 vs. -1.1±1.0cm, P=0.02) and depth (-1.0±0.5 vs. -0.5±0.5cm, P&lt;0.001), and erythema rate (100% vs. 80%, P=0.01). In addition, in supplemented patients changes in serum insulin concentration (-3.4±9.2 vs. +2.8±9.3 μIU/mL, P=0.01), homeostasis model of assessment-estimated insulin resistance (-1.5±4.1 vs. +1.7±5.1, P=0.01), the quantitative insulin sensitivity check index (+0.006±0.02 vs. -0.006±0.02, P=0.03) and HbA1c (-0.6±0.6 vs. -0.1±0.5%, P=0.004) were significantly different from those of patients in the placebo group. Additionally, following supplementation with vitamin D, significant reductions in serum total- (-15.8±18.9 vs. +5.3±31.8mg/dL, P=0.003), LDL- (-17.2±19.8 vs. +2.2±28.6mg/dL, P=0.003), total-/HDL-cholesterol ratio (-1.1±0.8 vs. -0.2±1.1, P=0.001), high sensitivity C-reactive protein (hs-CRP) (-0.4±2.5 vs. +1.9±4.2μg/mL, P=0.01), erythrocyte sedimentation rate (ESR) (-34.7±32.4 vs. -18.0±26.6mm/h, P=0.03) and plasma malondialdehyde (MDA) concentrations (-0.7±0.9 vs. -0.2±0.5μmol/L, P=0.008) were seen compared with the placebo. Conclusions: Overall, vitamin D supplementation for 12weeks among patients with DFU had beneficial effects on glucose homeostasis, total-, LDL-, total-/HDL-cholesterol, ESR, hs-CRP and MDA levels. In addition, vitamin D may have played an indirect role in wound healing due to its effect on improved glycemic control. 

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 A111 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 ,