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IRCT20180422039379N1 IRCT 2018-06-05 Ahvaz University of Medical Sciences Evaluation of oral and injection vitamin D3 on reducing statin-induced myopathy Comparison between the effect of oral and intravenous vitamin D3 on statin-induced myopathy level :Randomized Controlled Trial 2017-10-22 anticipated 50 Complete https://irct.ir/trial/30724 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The permutational block method is used for randomization, Blinding description: In this study the statistical analyzer does not know which patients are present in the group. 2 Statins myopathy. Intervention 1: Control group: For all patients Pearl, 50,000 units of vitamin D (Zahravi Company) will be given orally once a week for 8 weeks. ". Intervention 2: Intervention group: For all patients, 300,000 units of vitamin D (Caspian) will be given once a month for 2 months. ". No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Reza ganji
Ahvaz, Golestan Blvd., Jundishapur University of Medical Sciences, Ahvaz, Iran.
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8283 Rg.pharm77@gmail.com Ahvaz University of Medical Sciences scientific Reza ganji
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
Ahvaz Iran (Islamic Republic of) 6135733184 +98 61 1373 8378 Rg.pharm77@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) 1. There are symptoms of myalgia with statins 2. Age of patients aged 18 to 65 years. 3. Lower levels of vitamin D (25OH Vitamin D3) from normal range (<32ng / ml). 18 years 65 years Both 1. Patient does not provide consent. 2. Failure to complete the study 3. Age under 18 and over 65 years. 4. Alcohol or substance abuse. 5. Collagen disease, vascular, coagulopathy, genetic, cerebrovascular disease. 6. Creatine kinase level above 300U / L, indicating fibromyalgia. 7. The patient is not able to use Pearl vitamin D3 or a tendency to inject a drug. 8. The history and evidence of examination indicate trauma in the organs. G72.0 Drug-induced myopathy Treatment - Drugs Treatment - Drugs Control group: For all patients Pearl, 50,000 units of vitamin D (Zahravi Company) will be given orally once a week for 8 weeks. " Intervention group: For all patients, 300,000 units of vitamin D (Caspian) will be given once a month for 2 months. " "Measuring serum level of vitamin D3". Timepoint: "Measuring serum level of vitamin D3 at the beginning of the study (before the intervention) and at the end of the study (8 weeks after starting vitamin D)". Method of measurement: Serum levels of vitamin D were measured using ELISA method. "Measuring the severity of myopathy pain". Timepoint: "Measuring the severity of pain at the beginning of the study (before the intervention) and 8 weeks after taking vitamin D". Method of measurement: "Visual Analogue Scale (VAS)". Ahvaz University of Medical Sciences Approved 2017-10-13 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Ahwaz-Naderi Street-Corner, North Kathanafah Avenue-Dr. Zarger Nejad Pharmacy Ahvaz Khouzestan Iran (Islamic Republic of)