Effect of vitamin D in severe traumatic brain injury

Phase 3

Recruiting

• Conditions: Condition 1: Epidural hemorrhage. Condition 2: Traumatic subdural hemorrhage.; Epidural hemorrhage; Traumatic subdural hemorrhage; S06.4; S06.5

• Registration Number: IRCT20180619040151N3
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 5 November 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;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.;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.;28 days mortality. Timepoint: Measurement of mortality at the beginning of the study and day 28. Method of measurement: Death record.

Secondary Outcome Measures

Name	Time	Method
Delirium. Timepoint: Before intervention, day 7 and 14. Method of measurement: The Confusion Assessment Method for the ICU.;Glasgow coma score. Timepoint: Before intervention, day 7 and 14. Method of measurement: Glasgow Coma Scale.;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.;Sequential Organ Failure Assessment (SOFA) score. Timepoint: Before intervention, day 7 and 14. Method of measurement: Sequential Organ Failure Assessment (SOFA) Score.