Comparison of Oral and Injectable Dosage Forms of Vitamin D3 on Resolving Statin-Induced Myopathy: Single Blinded Randomized Controlled Clinical Trial

Abstract

Statin inhibits the HMG-CoA reductase enzyme, which lowers cholesterol levels in plasma. However, the use of this group of medicines has been associated with some side effects, including myopathy and muscle disorders. Various modalities have been suggested to reduce the occurrence of this adverse effect. Vitamin D has potential positive effects on muscle disorders and inflammatory diseases. This study examines the therapeutic effect of vitamin D on statin-induced myopathy. This study was a single-blinded randomized controlled clinical trial, performed on patients with statin-induced myopathy. Forty-three patients were randomly assigned into two groups by the random block method. The first group received pearl of vitamin D3 50,000 units orally for 8 weeks, while the second group received injected form of vitamin D3 300,000 IU per month. The McGill Pain Management (MPQ) questionnaire was filled out to collect information in six therapeutic sessions. For statistical analysis of data, software SPSS22 and covariance tests were performed. The results showed that supplemented vitamin D resulted in a significant reduction of pain and emotional perception (p < 0/05). Both serum levels of vitamin D level and VAS (visual analog scale) score increased significantly after both oral and injectable forms of vitamin D (p = 0.001). The results of the present study suggested that vitamin D, in both dosage forms of oral and injectable, could be administered as an effective modality to control pain in patients with statin-induced myopathy. Vitamin D could be considered as an inexpensive and available noninvasive approach by the healthcare team. Trial registration: IRCT20180422039379N1, Registration date: 2018-06-05 (https://www.irct.ir/trial/30724)