NCT03248544

Brief 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 with brain tumor under craniotomy will receive a single high dose vitamin D compared to control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

1.1 years

First QC Date

August 10, 2017

Last Update Submit

July 29, 2018

Conditions

Brain Neoplasms

Keywords

vitamin DBrain Neoplasmsperioperative complicationsclinical outcomescraniotomyImmune System

Outcome Measures

Primary Outcomes (1)

  • Vitamin D level

    25(OH) will be measured after surgery

    Postoperative day 5

Secondary Outcomes (6)

  • Peri-operative Complications

    During surgery, recovery and hospitalization (5 days post op)

  • Post-operative Complications

    30 days after surgery

  • Duration of stay in ICU

    30 days

  • Duration of stay in hospital

    30 days

  • 1-month mortality

    30 days

  • +1 more secondary outcomes

Study Arms (2)

vitamin D

EXPERIMENTAL

Intervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection

Drug: vitamin D

control

OTHER

Control patients will not be received any intervention

Other: control

Interventions

vitamin DDRUG

Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection

Also known as: Cholecalciferol
vitamin D
controlOTHER

No intervention

control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent of patient or legal representative
  • (OH)D level below 20ng/dL

You may not qualify if:

  • Other trial participation, including previous participation in the pilot trial
  • Pregnant or lactating women
  • Hypercalcemia
  • Hyperphosphatemia
  • Tuberculosis
  • Sarcoidosis
  • History of nephrolithiasis
  • History of hyperparathyroidis
  • Medications that interfere with vitamin D metabolism
  • Renal Insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences

Tehran, Iran

Location

Shohada Tajrish Hospital

Tehran, Iran

Location

Related Publications (1)

  • 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.

    PMID: 33487259DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Vitamin DCholecalciferol

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipids

Study Officials

  • Zahra Vahdat Shariatpanahi, MD, PhD

    Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 14, 2017

Study Start

July 6, 2017

Primary Completion

July 30, 2018

Study Completion

July 30, 2018

Last Updated

July 31, 2018

Record last verified: 2018-07

Locations

IR(2)