Brain NeoplasmsNCT03248544
Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Brain Tumor Surgery
A study testing vitamin D in people with Brain Neoplasms, run by Shahid Beheshti University at 2 sites in Iran.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms
- What is being tested?
- vitamin D
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesIran
- Study dates
- 6 Jul 2017to 30 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent of patient or legal representative
- 25(OH)D level below 20ng/dL
Who cannot join
- Other trial participation, including previous participation in the pilot trial
- Pregnant or lactating women
- Hypercalcemia
- Hyperphosphatemia
- Tuberculosis
- Sarcoidosis
Show all 10Show fewer
- History of nephrolithiasis
- History of hyperparathyroidis
- Medications that interfere with vitamin D metabolism
- Renal Insufficiency
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences
Tehran
Shohada Tajrish Hospital
Tehran
About this study
Official title: Effect of Single High Dose Vitamin D3 on Peri-operative and Post-operative Complications and Clinical Outcomes in Patients Under Craniotomy for Brain Tumor Resection
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.
Read the detailed description
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.
- Conditions
- Brain Neoplasms
- Being tested
- vitamin D, control
- Keywords
- vitamin D, Brain Neoplasms, perioperative complications, clinical outcomes, craniotomy, Immune System
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin DDrug
Also called Cholecalciferol
Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection
controlOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| vitamin D | Experimental | Intervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection Receives: Drug: vitamin D |
| control | Other | Control patients will not be received any intervention Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D level
25(OH) will be measured after surgery
Measured: Postoperative day 5
Secondary outcomes (6)
Peri-operative Complications
Complications in operating room, recovery room, ICU and neurosurgery ward
Measured: During surgery, recovery and hospitalization (5 days post op)
Post-operative Complications
Complications after hospital discharge
Measured: 30 days after surgery
Duration of stay in ICU
Length of stay in ICU is measured
Measured: 30 days
Duration of stay in hospital
Length of stay in hospital is measured
Measured: 30 days
1-month mortality
Mortality during hospitalization or 1 month after surgery
Measured: 30 days
6-month mortality
Mortality during 6 months after surgery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start6 Jul 2017
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Vahdat Shariatpanahi, Shahid Beheshti University
- Investigators
- Zahra Vahdat Shariatpanahi, MD, PhD, Study chair, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248544
- Sponsor's protocol ID
- 1396-607
- Status last verified
- Jul 2018
- First submitted
- 10 Aug 2017
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33487259
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Single High Dose Vitamin D3 on Peri-operative and Post-operative Complications and Clinical Outcomes in Patients Under Craniotomy for Brain Tumor Resection
- ClinicalTrials.gov ID
- NCT03248544
- Acronym / sponsor ID
- 1396-607
- Conditions
- Brain Neoplasms
- Keywords
- vitamin D, Brain Neoplasms, perioperative complications, clinical outcomes, craniotomy, Immune System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D | Experimental | Drug: vitamin DIntervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection |
| control | Other | Other: controlControl patients will not be received any intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent of patient or legal representative
- 25(OH)D level below 20ng/dL
Key exclusion criteria (10 listed)
- Other trial participation, including previous participation in the pilot trial
- Pregnant or lactating women
- Hypercalcemia
- Hyperphosphatemia
- Tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin DAlso: CholecalciferolFat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection | Drug | vitamin D |
| controlNo intervention | Other | control |
Primary outcome
Vitamin D level
Time frame: Postoperative day 5
25(OH) will be measured after surgery
6 secondary outcomes
Peri-operative Complications
Time frame: During surgery, recovery and hospitalization (5 days post op)
Post-operative Complications
Time frame: 30 days after surgery
Duration of stay in ICU
Time frame: 30 days
Duration of stay in hospital
Time frame: 30 days
1-month mortality
Time frame: 30 days
6-month mortality
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Derived from this study: PubMed 33487259Hajimohammadebrahim-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahra Vahdat Shariatpanahi, MD, PhD study chair
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D in people with Brain Neoplasms, run by Shahid Beheshti University at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D level (time frame: Postoperative day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03248544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.