The effect of vitamin D replacement therapy on the incidence of statin-related muscle complications in patients who have been recently treated with statin
Design
A concealed, randomized, blinded, controlled clinical trial with a parallel group design of 78 patients, enrolled between October 2016 to February 2017, were followed up for at least three months
Settings and conduct
Seventy-eight patients admitted to Afshar Hospital in Yazd who had been diagnosed with acute coronary syndrome in the center since October 2016 to February 2017, were treated with atorvastatin and low levels of vitamin D were included. Medication and placebo are named by a person who does not have an intervention in the treatment, to drug 1 and drug 2. One of these two is randomly injected by a nurse who is unaware of the nature of the drugs (the drugs are prescribed by the first person). So that neither patients nor therapists are aware of prescription drugs
Participants/Inclusion and exclusion criteria
Entry conditions: All patients who have been recently treated with atorvastatin
No entry conditions: Previous history of statin use; Previous history of Vitamin D Supplement use; having musculoscletal symptoms; history of musculoscletal disease; history of thyroid disease
Intervention groups
In one group, the injection of 300,000 units of vitamin D was administered muscularly and into another, placebo (sterile water injection) was administered
The effect of vitamin D replacement therapy on the incidence of statin associated muscle complications
Public title
The effect of Vitamin D on the prevention of statin associated muscle complications
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who have been recently treated with atorvastatin
Exclusion criteria:
Previous history of statin use
Previous history of Vitamin D Supplement use
having musculoscletal symptoms
history of musculoscletal disease
history of thyroid disease
Age
From 30 years old to 84 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Actual sample size reached:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual, Using the random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
Medication and placebo are named by a person who does not have an intervention in the treatment, to drug 1 and drug 2. One of these two is randomly injected by a nurse who is unaware of the nature of the drugs (the drugs are prescribed by the first person). So that neither patients nor therapists are aware of prescription drugs.
Placebo
Used
Assignment
Parallel
Other design features
Pilot study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Faculty of Medicine, Shahid Sadoughi University of Medical Sciences and Health Services; Professor Hesabi Blvd; Yazd Town
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2016-11-13, 1395/08/23
Ethics committee reference number
IR.SSU.MEDICINE.REC.1395.203
Health conditions studied
1
Description of health condition studied
Acute ischemic heart disease
ICD-10 code
I24.9
ICD-10 code description
Acute ischemic heart disease, unspecified
Primary outcomes
1
Description
Statin associated muscle symptom score
Timepoint
At the beginning of the study, 1, 2 and 3 months after the start of taking statin and administering vitamin D and placebo