Protocol summary
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Study aim
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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
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Design
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Two arm parallel group double blind randomized clinical trial with post-trauma care and outcome assessment
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Mortality, Interleukin- 6 (IL-1), C-Reactive Protein (CRP) , Monocyte chemoattractant protein-1 (MCP-1)
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180619040151N3
Registration date:
2019-08-10, 1398/05/19
Registration timing:
prospective
Last update:
2019-10-06, 1398/07/14
Update count:
1
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Registration date
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2019-08-10, 1398/05/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-08-11, 1398/05/20
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Expected recruitment end date
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2019-12-21, 1398/09/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Effect of vitamin D in severe traumatic brain injury
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-10-06, 1397/07/14
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1397.381
Health conditions studied
1
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Description of health condition studied
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Epidural hemorrhage
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ICD-10 code
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S06.4
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ICD-10 code description
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Epidural hemorrhage
2
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Description of health condition studied
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Traumatic subdural hemorrhage
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ICD-10 code
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S06.5
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ICD-10 code description
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Traumatic subdural hemorrhage
Primary outcomes
1
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Description
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Interleukin-6
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Timepoint
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Measurement of Interleukin-6 at the beginning of the study and on days 7 and 14 after vitamin D supplementation
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Method of measurement
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Serum measurement with ELISA method
2
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Description
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Monocyte Chemoattractant Protein-1 (MCP-1)
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Timepoint
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Measurement of Monocyte Chemoattractant Protein-1 at the beginning of the study and on days 7 and 14 after vitamin D supplementation
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Method of measurement
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Serum measurement with ELISA method
3
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Description
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C-reactive protein
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Timepoint
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Measurement of C-reactive protein at the beginning of the study and on days 7 and 14 after vitamin D supplementation
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Method of measurement
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Serum measurement with ELISA method
4
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Description
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28 days mortality
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Timepoint
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Measurement of mortality at the beginning of the study and day 28
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Method of measurement
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Death record
Secondary outcomes
1
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Description
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Delirium
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Timepoint
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Before intervention, day 7 and 14
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Method of measurement
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The Confusion Assessment Method for the ICU
2
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Description
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Glasgow coma score
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Timepoint
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Before intervention, day 7 and 14
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Method of measurement
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Glasgow Coma Scale
3
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Description
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Acute Physiology and Chronic Health Evaluation (APACHE II) score
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Timepoint
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Before intervention, day 7 and 14
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Method of measurement
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Acute Physiology and Chronic Health Evaluation (APACHE II) score
4
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Description
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Sequential Organ Failure Assessment (SOFA) score
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Timepoint
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Before intervention, day 7 and 14
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Method of measurement
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Sequential Organ Failure Assessment (SOFA) Score
Intervention groups
1
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Description
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Intervention group: drop of vitamin D3, 100000 IU daily for 5 days, and 1000 IU daily from day 6 to day 14
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Category
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Treatment - Drugs
2
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Description
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Control group: drop of vitamin d3 1000 IU, daily for 14 days
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available