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

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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)

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Data availability

The datasets used and/or analyzed during the current study available from the corresponding author on reasonable request. The raw SPSS file of this study before analysis is available upon your request.

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Acknowledgments

The authors gratefully acknowledge the Vice Chancellor of Research and Technology Affairs of Jundishapur University of Medical Sciences for financial support.

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“Not applicable.”

Funding

This study was financially supported by a grant from Vice Chancellor of Research and Technology affairs of Jundishapur University of Medical Sciences, Ahvaz, Iran.

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Authors and Affiliations

  1. Department of Clinical Pharmacy, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

    Reza Ganji

  2. School of Pharmacy, International Campus of Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

    Ahmad Sa’dinpour

  3. Department of Cardiology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

    Seyed Massoud Seyedian

  4. Department of Epidemiology and Biostatistics, School of Health, Tehran University of Medical Sciences, Tehran, Iran

    Saeed Hesam

  5. Shadean General Hospital, Ahvaz (Abadan) University of Medical Science, Shadegan, Iran

    Nader Afshari

  6. Clinical Research Center, Department of Internal Medicine, North Khorasan University of Medical Sciences, Bojnurd, Iran

    Adeleh Sahebnasagh

Authors
  1. Reza Ganji
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  2. Ahmad Sa’dinpour
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  3. Seyed Massoud Seyedian
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  4. Saeed Hesam
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  5. Nader Afshari
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  6. Adeleh Sahebnasagh
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Contributions

RG: the principal investigator and manager of the study, design, and conduction of the study. AS: collecting data and drafting the manuscript. SMS: head of treatment team, supervising on data records. SH: analysis and interpreting data. NA: study design and treatment team. AS: conception in the design of the study, data drafting the manuscript, and submission.

Corresponding author

Correspondence to Adeleh Sahebnasagh.

Ethics declarations

Ethics Approval and Consent to Participate

The ethical committee of Jundishapur University of Medical Sciences approved the study protocol (Ethics Code; AJUMS.REC.1396.527). All patients received verbal and printed information, and all provided written consent before entry into this study.

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“Not applicable.”

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The authors declare no conflict of interest.

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Ganji, R., Sa’dinpour, A., Seyedian, S.M. et al. Comparison of Oral and Injectable Dosage Forms of Vitamin D3 on Resolving Statin-Induced Myopathy: Single Blinded Randomized Controlled Clinical Trial. SN Compr. Clin. Med. 3, 1555–1560 (2021). https://doi.org/10.1007/s42399-021-00906-3

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