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Effect of vitamin D in severe traumatic brain injury

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.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180619040151N3
Enrollment
70
Registered
2019-08-10
Start date
2019-08-11
Completion date
Unknown
Last updated
2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Epidural hemorrhage. Condition 2: Traumatic subdural hemorrhage. Epidural hemorrhage Traumatic subdural hemorrhage

Interventions

Intervention 1: Intervention group: drop of vitamin D3, 100000 IU daily for 5 days, and 1000 IU daily from day 6 to day 14. Intervention 2: Control group: drop of vitamin d3 1000 IU, daily for 14 days

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Mostafa Arabi

Mashhad University of Medical Sciences

arabim941@mums.ac.ir+98 51 3882 7033

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 17, 2026