Clinical evaluation of the effects of Ascorbic acid on attenuation of the statin induced myopathy: a randomized double blinded placebo-controlled clinical trial
Clinical evaluation of the effects of vitamin C on attenuation of the statin induced myopathy
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 is performed on 40 patients and the RND() function of Excel software is used for randomization.
Serum enzyme levels are measured 24 hours after exercise and they receive medication and placebo daily for two weeks. After 2 weeks, the serum levels of their enzymes are measured again 24 hours after exercise.
People between 80-30 years old; Patients undergoing exercise for cardiac rehabilitation; Daily intake of 40 mg atorvastatin; Maximum weight 80 kg; Non-pregnancy of women; The patient should not have severe peptic ulcer
Intervention groups
Daily consumption of two drug or plasebo for 14 days
Main outcome variables
Blood levels of creatine kinase, aldolase and lactate dehydrogenase enzymes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191106045356N2
Registration date:2021-04-18, 1400/01/29
Registration timing:prospective
Last update:2021-04-18, 1400/01/29
Update count:0
Registration date
2021-04-18, 1400/01/29
Registrant information
Name
Mohsen Zabihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3865
Email address
mzabihi100@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-20, 1400/02/30
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of the effects of Ascorbic acid on attenuation of the statin induced myopathy: a randomized double blinded placebo-controlled clinical trial
Public title
evaluation of the effects of Ascorbic acid on attenuation of the statin induced myopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People between 80-30 years old
Patients undergoing exercise for cardiac rehabilitation
Daily intake of 40 mg of atorvastatin
Maximum weight 80 kg
Non-pregnancy of women
The patient should not have severe peptic ulcer
Exclusion criteria:
Vitamin C intolerance
Do not take medication for more than two consecutive days
Do not take atorvastatin for more than two consecutive days
The patient becomes pregnant
Age
From 30 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed based on the RND function of Excel software and patients are divided into two groups A and B. The drug and placebo are uniform and coded in terms of the shape of the drug and the drug container, and the patient and the physician prescribing the drug and the evaluator do not know the composition and content of each drug container.
Blinding (investigator's opinion)
Double blinded
Blinding description
Different groups of drugs are placed in uniform and coded containers, and the prescribing physician and the evaluator do not know the composition and content of each drug container.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916978447
Approval date
2021-03-21, 1400/01/01
Ethics committee reference number
1111
Health conditions studied
1
Description of health condition studied
Myopathy
ICD-10 code
G72.0
ICD-10 code description
Drug-induced myopathy
Primary outcomes
1
Description
Creatine kinase, aldolase and lactate dehydrogenase levels
Timepoint
Evaluation of patient tests on days 1 and 14 of the intervention
Method of measurement
Patient blood test and measurement of creatine kinase, aldolase and lactate dehydrogenase using relevant kits
Secondary outcomes
empty
Intervention groups
1
Description
Includes 20 patients who are randomly selected based on the RND() function of Excel software. Patients receive two 500 mg of vitamin C capsules daily made by an Iranian pharmaceutical company for 14 days, and on days 1 and 14, 24 hours after cardiac rehabilitation exercise, using a blood test for creatine kinase, lactate dehydrogenase and aldolase enzymes are measured.
Category
Treatment - Drugs
2
Description
Includes 20 patients who are randomly selected based on the RND() function of Excel software. Patients receive two starch capsules daily for 14 days, and on days 1 and 14, 24 hours after cardiac rehabilitation exercise, using a blood test for creatine kinase, lactate dehydrogenase and aldolase enzymes are measured.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar hospital
Full name of responsible person
Dr. Mohsen Zabihi
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Mirzaie
Street address
Bahonar sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available