Evaluating the effect of high dose vitamin D on Neuron Specific Enolase blood level as a neuronal damage biomarker
Design
Two arms open-label parallel-group randomized (by RAND function of Excel software) clinical trial including two groups of intervention and control, on ۴۰ patients
Settings and conduct
In this study, 40 patients with moderate ischemic stroke (NIHSS 5-15) will be recruited from the neurology clinics of Imam Hossein Hospital, Tehran. Patients will be randomly assigned into groups A (intervention group) and B (control group). Subjects in group A will receive a single dose of 600000 units of vitamin D by intramuscular injection besides standard treatment. Five milliliters of the blood sample will be gathered from each subject before the entrance to the study and 3 days after recruitment in order to measure neuron-specific enolase level. To evaluate the clinical impact of the intervention, NIHSS will be measured daily until the patient is hospitalized and Barthel index will be measured 3 months after stroke
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 16 to 75 years suffered from moderate ischemic stroke (NIHSS 5-15)
Exclusion criteria: Patients who had myocardial infarction 30 days before the stroke and vitamin D blood level more than 30ng/ml
Intervention groups
Intervention group: Subjects who will receive a single dose of 600,000 units of vitamin D by IM injection pulse standard care
Control group: Patients who will receive standard care
Main outcome variables
Changes of neuron-specific enolase between two arms of the study
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120703010178N24
Registration date:2021-04-09, 1400/01/20
Registration timing:registered_while_recruiting
Last update:2021-04-09, 1400/01/20
Update count:0
Registration date
2021-04-09, 1400/01/20
Registrant information
Name
Mohammad Sistanizad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0087
Email address
sistanizadm@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of high dose vitamin D on serum Neuron Specific Enolase (NSE) level as a marker of neuronal damage in patients with ischemic stroke
Public title
Effect of high dose vitamin D in patients with ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Ischemic Stroke
Patients over 16
Exclusion criteria:
Myocardial infarction in past 30 days
Vitamin D level more than 30ng/ml
Age
From 16 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
Blood sample
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to intervention and control arms of the study by simple randomization method using a series of unique random numbers generated by the RAND function in Excel software as below:
1- In column A, numbers 1-30 and 31 to 60 categorized as control and intervention, respectively.
2- In column B, the RAND function was run.
3- Columns A and B were copied and the values pasted in another sheet.
4- The sheet was sorted based on column B. So, the subjects in column A (control and intervention) were distributed randomly based on the random numbers generated in column B.
5- Numbers 1 to 60 were allocated in column C as subject number. Column B was deleted
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 Shahid Beheshti University of Medical Sciences
Street address
Velenjak Street, Shahid Chamran High Way
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-09-20, 1399/06/30
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1399.213
Health conditions studied
1
Description of health condition studied
ischemic stroke
ICD-10 code
163.9
ICD-10 code description
ischemic stroke
Primary outcomes
1
Description
Changes in the neuron-specific enolase between two arms of the study
Timepoint
Before intervention and 3 days after intervention
Method of measurement
EIA kit for the measurement of neuron-specific enolase
Secondary outcomes
1
Description
National Institutes of Health Stroke Scale
Timepoint
Daily until hospital discharge
Method of measurement
National Institutes of Health Stroke Scale questioner
2
Description
Barthel index
Timepoint
3 months after stroke
Method of measurement
Barthel index questioner
Intervention groups
1
Description
Intervention group: Patients receiving 600000 international unit of intramuscular vitamin D in day 0
Category
Treatment - Drugs
2
Description
Control group: Patients receiving standard treatment
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology clinic, Imam Hussein hospital
Full name of responsible person
Omid Hesami
Street address
Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 8081
Fax
Email
Tomyseti2009@yahoo.com
Web page address
http://www.ehmc.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tahereh Shams
Street address
Shahid Beheshti medical University, aarabi St., Yemen St., chamran Hwy, Velenjak St.
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 23 87121
Email
info@sbmu.ac.ir
Web page address
http://pharmacy.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Omid Hesami
Position
Neurologist / Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Tehran, Shahid Madani Alley, below Shahid Madani Metro, Imam Hossein Medical, Educational, Research and Treatment Center.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 0087
Fax
Email
hesami.omid@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sistanizad
Position
Associate Professor / Clinical Pharmacy Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0087
Fax
Email
sistanizadm@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Iranshahi setare
Position
Pharmacy student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Province
Tehran
Postal code
3371875158
Phone
+98 21 8867 0949
Fax
Email
tomyseti2009@yahoo.com
Web page address
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