Comparison of oral and intravenous vitamin D3 in reducing statin myopathy
Design
Phase 2 of the clinical trial has a control group that is community-oriented and pragmatic. With parallel groups. One blind and randomized sample of 50 people
Settings and conduct
This study is a randomized single-blind clinical trial of patients with statin-induced myopathy in Golestan Hospital. written and oral consent will be received from all of the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1.The presence of symptoms of myalgia in the 60 days of initiation or increase in the dose of statins.
2. Age of patients aged 18 to 65 years.
3. Decrease vitamin D (25OH Vitamin D3) levels from normal range (<32ng / ml).
Exclusion criteria:
1. Company's dissatisfaction with the study.
2. Failure to study.
3. Drinking alcohol or drugs.
4. Collagen disease, vascular, coagulopathy, genetic, cerebrovascular disease.
5. Creatine kinase level above 300U / L, indicating fibromyalgia.
6. The patient is not able to use Pearl vitamin D3 or a tendency to inject a drug.
7. The history and evidence of examination indicate trauma in the organs.
Intervention groups
. Control group: For patients, 50000 units of vitamin D (ergocalciferol) are administered orally once a week for 8 weeks.
Intervention group: For patients, two doses of IU 300,000 are given at intervals of one month for 8 weeks.
Main outcome variables
For all patients, the levels of vitamin D, muscle creatine phosphokinase (CPK), serum Ca level and serum P levels are measured at the beginning of the study and at the end of the study (after 8 weeks). A 10-cm visual analogue scale (VAS) questionnaire is used to assess pain in patients at the beginning of the study and at the end of the study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180422039379N1
Registration date:2018-06-05, 1397/03/15
Registration timing:retrospective
Last update:2018-06-05, 1397/03/15
Update count:0
Registration date
2018-06-05, 1397/03/15
Registrant information
Name
Ahmad Sadinpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3554 2180
Email address
sadinpoor.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-22, 1396/07/30
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2017-10-22, 1396/07/30
Actual recruitment end date
2017-12-21, 1396/09/30
Trial completion date
empty
Scientific title
Comparison between the effect of oral and intravenous vitamin D3 on statin-induced myopathy level :Randomized Controlled Trial
Public title
Evaluation of oral and injection vitamin D3 on reducing statin-induced myopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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).
Exclusion criteria:
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.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
43
Randomization (investigator's opinion)
Randomized
Randomization description
The permutational block method is used for randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study the statistical analyzer does not know which patients are present in the group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahwaz-Naderi Street-Corner, North Kathanafah Avenue-Dr. Zarger Nejad Pharmacy
City
Ahvaz
Province
Khouzestan
Postal code
6193944166
Approval date
2017-10-13, 1396/07/21
Ethics committee reference number
IR.AJUMS.REC.1396.527
Health conditions studied
1
Description of health condition studied
Statins myopathy
ICD-10 code
G72.0
ICD-10 code description
Drug-induced myopathy
Primary outcomes
1
Description
"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.
2
Description
"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)"
Secondary outcomes
empty
Intervention groups
1
Description
Control group: For all patients Pearl, 50,000 units of vitamin D (Zahravi Company) will be given orally once a week for 8 weeks. "
Category
Treatment - Drugs
2
Description
Intervention group: For all patients, 300,000 units of vitamin D (Caspian) will be given once a month for 2 months. "
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Ahmad sadinpour
Street address
Ahvaz Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6193944166
Phone
+98 61 3223 3475
Email
sadinpourahmad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ahmad sadinpour
Street address
Ahvaz / Golestan / Jundishapur University / School of Pharmacy
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8283
Email
sadinpourahmad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Reza ganji
Position
PHD
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ahvaz, Golestan Blvd., Jundishapur University of Medical Sciences, Ahvaz, Iran.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8283
Email
Rg.pharm77@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza ganji
Position
Ph.D. in Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 1373 8378
Email
Rg.pharm77@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ahmad sadinpour
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Ahwaz University of Jundishapur. Faculty of Pharmacy
City
Ahvaz
Province
Khouzestan
Postal code
6193944166
Phone
+98 61 1373 8378
Email
sadinpourahmad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD