Effect of vitamin D on short-term prognosis of acute ischemic stroke
Design
Clinical trial with control group, with parallel groups, randomized, phase 3 on 40 patients, randomization list through www. sealedenvelope.com/simple-randomiser/v1/lists
Settings and conduct
Patients with acute ischemic stroke referred to Shahid Beheshti hospital clinic in Kashan will be randomly divided into two intervention groups (receive a single dose of vitamin D + standard treatment) and control (standard treatment). MRS will be evaluated and recorded for all patients at the beginning of the study, and in order to measure the level of vitamin D, a larger sample volume of 2 to 3 cc will be taken and sent to the hospital laboratory. In addition to standard treatments, patients in the intervention group receive a single dose of intramuscular vitamin D injection (300,000 IU) up to 24 hours from the onset of symptoms, and patients in the control group receive standard treatment. After six weeks, vitamin D levels and Modified Rankin Scale (MRS) will be measured and compared for both groups.
Participants/Inclusion and exclusion criteria
Patients over 18 years old with acute ischemic stroke
Intervention groups
Intervention group: single dose intramuscular vitamin D injection (300,000 IU) + standard treatment
Control group: standard treatment
Main outcome variables
disability severity (MRS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220702055334N1
Registration date:2022-07-11, 1401/04/20
Registration timing:prospective
Last update:2022-07-11, 1401/04/20
Update count:0
Registration date
2022-07-11, 1401/04/20
Registrant information
Name
Arezoo Jafarian yazdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 1168
Email address
jafarian-a@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D on short-term prognosis of acute ischemic stroke
Public title
Effect of vitamin D on short-term prognosis of acute ischemic stroke
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years of age with acute ischemic stroke diagnosed by clinical examination and CT scan findings
Exclusion criteria:
Admission after 24 hours from the onset of symptoms
NIHSS >15 at admission
being treated with vitamin D (at least the last 3 months)
Receive alteplase
History of malignancy
Age
From 19 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
First, the intervention group was coded with the letter A and the control group with the letter B, and then using the website www. sealedenvelope.com/simple-randomiser/v1/lists randomization list was prepared by selecting a sample size of 40 (two groups of 20) and permuted block randomization method (block size=4) (10 blocks of 4). Then, through the obtained randomization list, the subjects included in the study will be assigned to one of the two groups A or B. For example, suppose that in the first four blocks, the permutation method is ABBA, so the first and fourth samples will be assigned to group A and the second and third samples to group B and the same will continue until the last sample (40th person).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Qutb Ravandi Boulevard - Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2022-06-19, 1401/03/29
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1401.042
Health conditions studied
1
Description of health condition studied
Acute ischemic stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Disability severity (MRS)
Timepoint
At the beginning of the study, six weeks after the intervention
Method of measurement
MRS specific scoring system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group patients up to 24 hours from the onset of symptoms in addition to standard treatments (including antiplatelet (aspirin 325 mg stat and 80 mg daily), lipid lowering agent (atorvastatin 80 mg acetate and 40 mg twice a day), hydration (an average of 1.5 L normal daily saline) and pantoprazole (40 mg daily) according to the conditions of each patient), are subjected to a single dose of intramuscular vitamin D injection (300,000 IU) from Osveh made in Iran.
Category
Treatment - Drugs
2
Description
Control group: Standard treatment Including antiplatelet (aspirin 325 mg stat and 80 mg daily), lipid lowering agent (atorvastatin 80 mg acetate and 40 mg twice a day), hydration (an average of 1.5 L normal daily saline) and pantoprazole (40 mg daily) according to the conditions of each patient
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Shahid Beheshti Hospital Clinic
Full name of responsible person
Arezoo Jafarian Yazdi
Street address
Qutb Ravandi Boulevard, Shahid Beheshti Hospital
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9227
Email
beheshtihospital@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Banafsheh
Street address
Qutb Ravandi Blvd., University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9399
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Arezoo Jafarian Yazdi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Motahari Street, Mir Emad 10, No. 7, Unit 19
City
Tehran
Province
Isfehan
Postal code
1587836151
Phone
+98 21 2256 1168
Email
Arezoo.jafarian1991@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Massoud
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Qutb Ravandi Boulevard, Shahid Beheshti Hospital
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9333
Email
beheshtihospital@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Arezoo Jafarian Yazdi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Motahari Street, Mir Emad 10, No. 7, Unit 19
City
Tehran
Province
Isfehan
Postal code
1587836151
Phone
+98 21 2256 1168
Email
Arezoo.jafarian1991@yahoo.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