Comparison of the efficacy of high and low doses vitamin D supplementation on serum levels of inflammatory factors and mortality in patients with severe head trauma.
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General information
2019-06-22, 1398/04/01
2019-08-11, 1398/05/20
2019-0608-2211 00:00:00
2019-10-23, 1398/08/01
2019-12-21, 1398/09/30
2019-1012-2321 00:00:00
Recruitment centers
#1
Name of recruitment center - English: Shahid Kamyab hospital
Name of recruitment center - Persian: بیمارستان شهید کامیاب
Full name of responsible person - English: Abdolreza Norouzy
Full name of responsible person - Persian: عبدالرضا نوروزی
Street address - English: Azadi squer, Mashhad university of medical sciences
Street address - Persian: دانشگاه علوم پزشکی مشهد، میدان آزادی
City - English: mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9177948564
Phone: +98 51 3882 7033
Fax:
Email: norouzya@mums.ac.ir
Web page address:
Name of recruitment center - English: Shahid Kamyab hospital
Name of recruitment center - Persian: بیمارستان شهید کامیاب
Full name of responsible person - English: Abdolreza Norouzy
Full name of responsible person - Persian: عبدالرضا نوروزی
Street address - English: Fadaian Eslam street
Street address - Persian: خیابان فدائیان اسلام
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9177948564
Phone: +98 51 3882 7033
Fax:
Email: norouzya97@gmail.com
Web page address:
Name of recruitment center - English: Shahid Kamyab hospital Name of recruitment center - Persian: بیمارستان شهید کامیاب Full name of responsible person - English: Abdolreza Norouzy Full name of responsible person - Persian: عبدالرضا نوروزی Street address - English: Azadi squer, Mashhad university of medical sciencesFadaian Eslam street Street address - Persian: دانشگاه علوم پزشکی مشهد، میدان آزادیخیابان فدائیان اسلام City - English: mashhadMashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9177948564 Phone: +98 51 3882 7033 Fax: Email: norouzyanorouzya97@mums.ac.irgmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohsen Tafaghodi
Full name of responsible person - Persian: محسن تفقدی
Street address - English: Mashhad University of Medical Sciences, 18 Daneshgah Ave. Daneshgah Ave
Street address - Persian: خیابان دانشگاه، خیابان دانشگاه 18، دانشگاه علوم پزشکی مشهد
City - English: Mashhad
City - Persian: مشهد
Province: South Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9196773117
Phone: +98 51 1882 3255
Fax: +98 51 1882 3251
Email: tafaghodim@mums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohsen Tafaghodi
Full name of responsible person - Persian: محسن تفقدی
Street address - English: Mashhad University of Medical Sciences, Daneshgah 18 Avenue, Daneshgah street
Street address - Persian: خیابان دانشگاه، خیابان دانشگاه 18، دانشگاه علوم پزشکی مشهد
City - English: Mashhad
City - Persian: مشهد
Province: South Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9196773117
Phone: +98 51 1882 3255
Fax: +98 51 1882 3251
Email: tafaghodim@mums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mohsen Tafaghodi Full name of responsible person - Persian: محسن تفقدی Street address - English: Mashhad University of Medical Sciences, Daneshgah 18 Avenue, Daneshgah Ave. Daneshgah Avestreet Street address - Persian: خیابان دانشگاه، خیابان دانشگاه 18، دانشگاه علوم پزشکی مشهد City - English: Mashhad City - Persian: مشهد Province: South Khorasan Country: Iran (Islamic Republic of) Postal code: 9196773117 Phone: +98 51 1882 3255 Fax: +98 51 1882 3251 Email: tafaghodim@mums.ac.ir Web page address:
Protocol summary
Study aim
Comparison of the effect of high and low doses of vitamin D supplementation on serum levels of inflammatory factors and mortality rate in patients with severe head trauma
Design
Two arm parallel group double blind randomized clinical trial with post-trauma care and outcome assessment
Settings and conduct
The VITdAL-ICU study is a randomized, double-blind, placebo-controlled trial investigating the effects of a daily dose of 100000 IU vitamin D3 versus 1000 IU vitamin D3 for 5 days on inflammatory makers and mortality rate (primary outcomes) in severe traumatic brain injury adults. Participants (N = 70, age 18-65 years) were recruited from the neurocritical care unit from Kamyab and Taleqani hospitals. Eligibility criteria included the presence of traumatic brain injury, Glasgow coma scale between 7 -9 and serum 25-hydroxyvitamin D levels lower than 20 nmol/L. Patients are randomly assigned to intervention group (A) and control (B) and receive daily coded vitamin D drops.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Head trauma, Glasgow coma scale (GCS) between 7 to 9, vitamin D level less than 20 nmol / g. Exclusion criteria: receive corticosteroid, total parenteral nutrition, age above 65 years old
Intervention groups
In the intervention group, vitamin D, 100,000 IU per day is given. In the control group vitamin D, 1000 IU per day is prescribed by gavage.
Comparison of the efficacy of high and low doses vitamin D supplementation on serum levels of inflammatory factors and mortality in patients with severe head trauma.
Public title
Effect of vitamin D in severe traumatic brain injury
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having vitamin D levels below 20 nmol/g/ml at the time of admission in the ICU
Glasgow coma scale (GCS) Between 7 and 9
Completion of informed consent form from patients' first-degree reletives
Achieving hemodynamic stability (no arterial pressure lower than 60 mmHg for at least 3 hours, stopping development epidoral, subdural or interacranial hematoma)
Entreal ability to feed in the first 24 to 48 hours of admission
Receiving the standard dose of Dilantin according to the treatment protocol for patients with traumatic brain injury
Age 18 to 65 years
Exclusion criteria:
Receiving Corticosteroids
Severe and active bleeding
Receive hydrochlorothiazide, digoxin and magnesium-containing antioxidants
History of treatment with a high dose of 1000 units of vitamin D in the last 4 months
Sepsis and pneumonia at the beginning of the study
Hyperparathyroidism, sarcoidosis, nephrolithiasis, chronic renal failure, cirrhosis and AIDS
Presence of autoimmune disease
Hypercalcemia at the beginning of the study (calcium-albumin more than 10.8)
Cancer, diabetes, and cardiovascular disease
Pregnancy
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the permuted block randomization method with blocks of size 4 is used. According to the sample size of 80, 20 blocks of size four will be produced using the online site (www.sealedenvelope.com).
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to apply blur in the randomization process, unique codes will be used on supplemental boxes, which will be generated by this software. By entering each individual into a study based on the sequence produced, the boxes of the drug that the code is registered on is assigned to the person and therefore, before the person is selected, one does not know the type of treatment he receives. Given that the box of vitamin D and placebo are named by the codes , the investigator, the patient, and the data analyzer are blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2018-10-06, 1397/07/14
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.381
Health conditions studied
1
Description of health condition studied
Epidural hemorrhage
ICD-10 code
S06.4
ICD-10 code description
Epidural hemorrhage
2
Description of health condition studied
Traumatic subdural hemorrhage
ICD-10 code
S06.5
ICD-10 code description
Traumatic subdural hemorrhage
Primary outcomes
1
Description
Interleukin-6
Timepoint
Measurement of Interleukin-6 at the beginning of the study and on days 7 and 14 after vitamin D supplementation
Method of measurement
Serum measurement with ELISA method
2
Description
Monocyte Chemoattractant Protein-1 (MCP-1)
Timepoint
Measurement of Monocyte Chemoattractant Protein-1 at the beginning of the study and on days 7 and 14 after vitamin D supplementation
Method of measurement
Serum measurement with ELISA method
3
Description
C-reactive protein
Timepoint
Measurement of C-reactive protein at the beginning of the study and on days 7 and 14 after vitamin D supplementation
Method of measurement
Serum measurement with ELISA method
4
Description
28 days mortality
Timepoint
Measurement of mortality at the beginning of the study and day 28
Method of measurement
Death record
Secondary outcomes
1
Description
Delirium
Timepoint
Before intervention, day 7 and 14
Method of measurement
The Confusion Assessment Method for the ICU
2
Description
Glasgow coma score
Timepoint
Before intervention, day 7 and 14
Method of measurement
Glasgow Coma Scale
3
Description
Acute Physiology and Chronic Health Evaluation (APACHE II) score
Timepoint
Before intervention, day 7 and 14
Method of measurement
Acute Physiology and Chronic Health Evaluation (APACHE II) score
4
Description
Sequential Organ Failure Assessment (SOFA) score
Timepoint
Before intervention, day 7 and 14
Method of measurement
Sequential Organ Failure Assessment (SOFA) Score
Intervention groups
1
Description
Intervention group: drop of vitamin D3, 100000 IU daily for 5 days, and 1000 IU daily from day 6 to day 14
Category
Treatment - Drugs
2
Description
Control group: drop of vitamin d3 1000 IU, daily for 14 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Kamyab hospital
Full name of responsible person
Abdolreza Norouzy
Street address
Fadaian Eslam street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7033
Email
norouzya97@gmail.com
2
Recruitment center
Name of recruitment center
Shahid Kamyab hospital
Full name of responsible person
Abdolreza Norouzy
Street address
North Azadi Ave
City
Mshhad
Province
Razavi Khorasan
Postal code
9177948565
Phone
+98 51 3842 9924
Email
norouzya97@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Daneshgah 18 Avenue, Daneshgah street
City
Mashhad
Province
South Khorasan
Postal code
9196773117
Phone
+98 51 1882 3255
Fax
+98 51 1882 3251
Email
tafaghodim@mums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Mostafa Arabi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7033
Email
arabim941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Mostafa Arabi
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Azadi squer, Mashhad university of medical sciences
City
mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7033
Email
arabim941@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Mostafa Arabi
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Azadi squer, Mashhad university of medical sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7033
Email
Arabim941@mums.ac.ir
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
No - There is not 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