The effect of neuroprotective vitamin D in brain trauma patients in Imam Khomeini hospital in Sari
Design
A randomized, controlled, A blind strain, placebo-controlled clinical trial
Settings and conduct
The Neurosurgery Department of Imam Khomeini Hospital in Sari has six months to collect the samples.
Participants/Inclusion and exclusion criteria
All patients admitted to the emergency department and then transferred to the neurosurgery ward or the ICU during the study period, in the census, without voluntary selection, make up the sample size.
Patients with brain death, grade 3 consciousness, patients who are hospitalized for less than 5 days, penetrating cerebral trauma, severe non-cerebral lesions such as hemotorax or hemo-peritoneum, or any injuries requiring rapid surgery, and There was no opportunity for neurological examination in the early stages and vitamin D deficiency was reported based on standard amounts. And less than 30 ng and more than 60 ng / ml
Intervention groups
1. In the first group, administration of VDH is performed in a single dose (150,000 units) after admission
The second group, the control group, is given placebo
Main outcome variables
level of consciousness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191026045243N2
Registration date:2019-12-23, 1398/10/02
Registration timing:retrospective
Last update:2019-12-23, 1398/10/02
Update count:0
Registration date
2019-12-23, 1398/10/02
Registrant information
Name
Sajad Shafiee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1630
Email address
sajad.shafiee@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of neuroprotective vitamin D on Traumatic Brain injury patients
Public title
A trial of neuroprotective vitamin D in traumatic brain injury patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients admitted to the emergency department and then transferred to the neurosurgery ward
All patients admitted to the emergency department and then transferred to the ICU ward
Exclusion criteria:
Patients with brain death
Equal degree of vigilance
Patients hospitalized for less than 5 days
Penetrating brain injuries
Accompanying severe lesions
Severe lesions other than brain injuries such as hemothorax or hemo-peritoneum or any injury requiring rapid surgery and no opportunity for neurological examination in the early stages.
itamin D deficiency according to the standard amount reported. And less than 30 ng and more than 60 ng / ml
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a randomized clinical trial in patients with inclusion criteria. Within 5 days of admission, the envelopes were placed in envelopes with specified numbers that were given to patients when administered by a nurse who did not know the contents of the envelopes. According to the patients in the two study groups, patients in group A received a single syringe containing 2 CC vitamin D and patients in group B received a placebo containing a single syringe containing 2 CC of distilled water. All patients will be screened for consciousness on the first day before the beginning of the split. In both groups, the status of consciousness will be re-evaluated and compared within 7 days after the last administration
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Imam Hospital of Sari, Mazandaran University of Medical Sciences
Street address
Neurosurgery Department, Imam Khomeini Hospital, Amir Mazandarani Ave.
City
Sari
Province
Mazandaran
Postal code
48166-33131
Approval date
2019-07-16, 1398/04/25
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1398.117
Health conditions studied
1
Description of health condition studied
Cerebral trauma
ICD-10 code
S06
ICD-10 code description
Intracranial injury
Primary outcomes
1
Description
Level of consciousness
Timepoint
Baseline and 7 and 90 days
Method of measurement
Glasgow level of consciousness
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All patients have vitamin D levels above 30. In the first group, daily VDH is administered for 5 days after admission and in the second group, the control group is given placebo.
Category
Treatment - Drugs
2
Description
Control group: All patients had vitamin D levels above 30 in the second group receiving placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hospital
Full name of responsible person
Sajad Shafiee
Street address
Amir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1700
Fax
+98 11 3336 1630
Email
sajad.shafiee@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
majid saeidi
Street address
Amir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1630
Fax
+98 11 3336 1630
Email
majid.saeidi125@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?