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Vitamin D supplementation not only has beneficial effects on morbidity and mortality in critically ill patients but it may also lead to alleviate of seizure, brain edema, infection, pain and some other perioperative complications, possibly in part through an attenuation of the immune response.In this trial patients with brain tumor under craniotomy will receive a single high dose vitamin D compared to control group.
A randomized, double blind, controlled trial will be conducted in neurosurgery ward, operating room (OR) and intensive care unit (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 60 eligible hospitalized patients that diagnosed with brain tumor and need to craniotomy, aged ≥ 18 years. Intervention patients will be received an intramuscular (IM) single dose of vitamin D (300000 IU). Patients will be evaluated for occurrence of perioperative complications and clinical outcomes immediately after surgery until 1 month later and 1 and 6 months mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D | Experimental | Intervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection |
|
| control | Other | Control patients will not be received any intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D | Drug | Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin D level | 25(OH) will be measured after surgery | Postoperative day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Peri-operative Complications | Complications in operating room, recovery room, ICU and neurosurgery ward | During surgery, recovery and hospitalization (5 days post op) |
| Post-operative Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zahra Vahdat Shariatpanahi, MD, PhD | Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences | Tehran | Iran | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33487259 | Derived | Hajimohammadebrahim-Ketabforoush M, Shahmohammadi M, Keikhaee M, Eslamian G, Vahdat Shariatpanahi Z. Single high-dose vitamin D3 injection and clinical outcomes in brain tumor resection: A randomized, controlled clinical trial. Clin Nutr ESPEN. 2021 Feb;41:153-159. doi: 10.1016/j.clnesp.2020.11.027. Epub 2021 Jan 2. |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| control | Other | No intervention |
|
Complications after hospital discharge
| 30 days after surgery |
| Duration of stay in ICU | Length of stay in ICU is measured | 30 days |
| Duration of stay in hospital | Length of stay in hospital is measured | 30 days |
| 1-month mortality | Mortality during hospitalization or 1 month after surgery | 30 days |
| 6-month mortality | Mortality during 6 months after surgery | 6 months |
| Shohada Tajrish Hospital |
| Tehran |
| Iran |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |