This is a randomized, double-blind clinical trial aimed to investigate the effects of calcitriol on neurological outcomes, oxidative stress and inflammatory parameters of 80 ischemic stroke referring Shahid Beheshti hospital in Kashan. Design: Inclusion criteria: patients with acute ischemic stroke symptoms age between 20 and 85 years. Exclusion criteria: Hemorrhagic stroke patients, daily intake of vitamin D3 (more than 800IU), high serum/urinary calcium level, high blood sugar, deep coma, pregnancy. Sample size of the study: 80 patients with stroke who referred to the Shahid Beheshti Hospital in Kashan University of Medical Sciences, Kashan, Iran, will be enrolled in the study. Intervention: case group received single oral dose of 10 ug calcitriol and control group (40 patients) will receive medium change triglyceride as placebo. Blood samples were collected at admission and 24 hours after intervention in order to determine oxidative stress and inflammatory biomarkers.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012532174N1
Registration date:2017-06-06, 1396/03/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-06, 1396/03/16
Registrant information
Name
Abolfazl Azami Tameh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5562 1158
Email address
aazami@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and innovation, Kashan University of Medical Sciences, project code 9586
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effects of calcitriol on inflammatory markers and improvement of neurological symptoms in stroke patients
Public title
stroke treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: acute ischemic stroke; age 20-85 years old
Exclusion Criteria: Hemorrhagic stroke; Vitamin D supplementation more than 800IU; High levels of calcium or phosphorus; Deep Coma
Age
From 20 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Qotb –e Ravandi Blvd.
City
Kashan
Postal code
8715988141
Approval date
2016-12-08, 1395/09/18
Ethics committee reference number
Ir.kaums.rec.1395.89
Health conditions studied
1
Description of health condition studied
Cerebral infarction
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction, unspecified
Primary outcomes
1
Description
Infact volume
Timepoint
before and 3 months after intervention
Method of measurement
CT- Scan
2
Description
Vitamine D
Timepoint
Before and 72 hours after intervention
Method of measurement
ELISA
3
Description
Calpain 1
Timepoint
Before and 24 hours after intervention
Method of measurement
flowcytometry
4
Description
IL-6
Timepoint
Before and 24 hours after intervention
Method of measurement
Real time PCR
5
Description
IL-1b
Timepoint
Before and 24 hours after intervention
Method of measurement
Real time PCR
6
Description
TNF-a
Timepoint
Before and 24 hours after intervention
Method of measurement
Real time PCR
7
Description
HSP27
Timepoint
Before and 24 hours after intervention
Method of measurement
ELISA
8
Description
TLR4
Timepoint
Before and 24 hours after intervention
Method of measurement
Real time PCR and flowcytometry
9
Description
MDA
Timepoint
Before and 24 hours after intervention
Method of measurement
ELISA
10
Description
NO
Timepoint
Before and 24 hours after intervention
Method of measurement
ELISA
11
Description
TAC
Timepoint
Before and 24 hours after intervention
Method of measurement
ELISA
12
Description
TLR2
Timepoint
Before and 24 hours after intervention
Method of measurement
Real time PCR and flowcytometry
Secondary outcomes
1
Description
Hypercalcemia
Timepoint
Before and 24 hours after intervention
Method of measurement
ELISA
2
Description
Hyperphosphatemia
Timepoint
Before and 24 hours after intervention
Method of measurement
ELISA
Intervention groups
1
Description
Intervention: case group received single oral dose of 10 ug calcitriol and control group (40 patients) will receive medium change triglyceride as placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Kashan University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Kuchaki
Street address
Pezeshk Blvd, Qotbe Ravandi Blvd
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research and innovation
Full name of responsible person
Dr. Ghalamali Hamidi
Street address
Qotb –e Ravandi Blvd.
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research and innovation
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Anatomy, School of Medicine, Kashan University of Medical Sciences,
Full name of responsible person
Dr. Abolfazl Azami Tameh
Position
Associate professor
Other areas of specialty/work
Street address
School of Medicin, Kashan University of Medical Sciences
City
Kashan
Postal code
8715988141
Phone
+98 31555621157
Fax
Email
aazami@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anatomical Sciences Research Center, Kashan University of Medical Sciences
Full name of responsible person
Dr. Abolfazl Azami Tameh
Position
Ph.D
Other areas of specialty/work
Street address
chool of Medicine, Kashan University of Medical Sciences
City
Kashan
Postal code
8715988141
Phone
+98 31555621158
Fax
Email
aazami@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Abolfazl Azami Tameh
Position
Associate professor
Other areas of specialty/work
Street address
Qotb –e Ravandi Blvd.
City
Kashan
Postal code
8715988141
Phone
+98 31555621158
Fax
Email
aazami@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)