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Effect of vitamin D in enhanced recovery after brain surgery

Acute effect of single high-dose vitamin D3 and the chronic effect of normal levels of 25-OHD on perioperative complications and clinical outcomes in brain tumor surgery patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190126042496N1
Enrollment
60
Registered
2019-07-24
Start date
2019-04-06
Completion date
Unknown
Last updated
2019-10-07

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

Conditions

Patients with brain tumors who have candidate for craniotomy surgery. Malignant neoplasm of brain

Interventions

Intervention 1: Intervention group: A group of patients with the serum level of 25OHD = 20 who are known that vitamin D deficiency. The injection of a single dose of vitamin D contains 300,000 units o

Sponsors

Neurofunctional Reseach Center of Shohada Tajrish Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: The willingness to cooperate and complete the informed consent form by the patient or legal surrogate The patient's age = 18 Definitive diagnosis of brain tumor and need craniotomy for resection Levels of 25-OHD = 20 ng/mL for intervention group Levels of 25-OHD > 30 ng/mL for normal group

Exclusion criteria

Exclusion criteria: Unwillingness to co-operate by the patients or their surrogate at the beginning of the study Participation in other clinical trials at the same time with this study Pregnancy and lactation Hypercalcemia Hyperphosphatemia Tuberculosis Sarcoidosis History of nephrolithiasis

Design outcomes

Primary

MeasureTime frame
Changes in serum levels of 25OHD before and after injection and surgery. Timepoint: Measurement of serum levels of 25OHD at the beginning of the study in all patients. Measurement of serum levels of 25OHD on the fifth day after surgery in intervention group who received a single high dose of vitamin D prior to surgery. Method of measurement: Laboratory measurements of 25OHD serum levels using Monobind kit by Enzyme-Linked Immunosorbent Assay (ELISA) method.

Secondary

MeasureTime frame
Intraoperative Active Bleeding. Timepoint: During surgery time. Method of measurement: Amount of blood loss (cc) during surgery based on estimation of anesthesiologist.;Incidence of ventricular fibrillation (VF) during surgery. Timepoint: During surgery time. Method of measurement: Based on doctor's diagnosis.;Incidence of cardiac arrest during surgery. Timepoint: During surgery time. Method of measurement: Based on doctor's diagnosis.;Incidence of severe bradycardia during surgery. Timepoint: During surgery time. Method of measurement: Based on doctor's diagnosis.;Incidence of hypotension during surgery. Timepoint: During surgery time. Method of measurement: Based on doctor's diagnosis.;Incidence of hypertension during surgery. Timepoint: During surgery time. Method of measurement: Based on doctor's diagnosis.;Incidence of intracranial hematoma after surgery. Timepoint: Immediately after surgery until the end of the hospitalization period for each patient (up to 1 month after surgery). Method of measurement: Based on doctor's diagnosis, computerized tomography (CT) scan, Magnetic resonance imaging (MRI).;Incidence of cerebral edema after surgery. Timepoint: Immediately after surgery until the end of the hospitalization period for each patient (up to 1 month after surgery). Method of measurement: Based on doctor's diagnosis, computerized tomography (CT) scan, Magnetic resonance imaging (MRI).;Incidence of seizure after surgery. Timepoint: Immediately after surgery until the end of the hospitalization period for each patient (up to 1 month after surgery). Method of measurement: Based on doctor's diagnosis.;Incidence of Myocardial Infarction (MI) after surgery. Timepoint: Immediately after surgery until the end of the hospitalization period for each patient (up to 1 month after surgery). Method of measurement: Based on doctor's diagnosis.;Incidence of Deep Vain Thrombosis (DVT) after surgery. Timepoint: Immediately after surgery until the end of the hospitalization pe

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadreza shahmohammadi

Shahid Beheshti University of Medical Sciences

mr_shahmohammadi@sbmu.ac.ir+98 21 23871

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026