AzTrials
AzTrials

Craniocerebral TraumaPhase 2/3NCT02881957

Hypovitaminosis D in Neurocritical Patients

A Phase 2/3 study testing Cholecalciferol in people with Craniocerebral Trauma and Intracranial Aneurysm, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Vitamin D has been shown to impact prognosis in a variety of retrospective and randomized clinical trials within an intensive care unit (ICU) environment. Despite these findings, there have been no studies examining the impact of hypovitaminosis D in specialized neurocritical care units (NCCU). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cholecalciferol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
274 participants
Where
1 siteUnited States
Study dates
10 Oct 2016to 10 Oct 2018
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients >18 years of age
  • Patients admitted to the neurosurgery or neurology services
  • Patients admitted to a critical care unit
  • Informed consent
  • Expected to stay in the ICU for 48 hours or more
  • Vitamin D deficiency (<20ng/mL)

Who cannot join

  • Patients where a vitamin D level was not drawn within 48 hours of admission
  • Patients not randomized within 48 hours of admission
  • Readmitted patients to the critical care unit
  • Lack of informed consent
  • Prior supplementation with vitamin D
  • Severely impaired gastrointestinal function
Show all 14Show fewer
  • Other trial participation
  • Pregnant or lactating women
  • Hypercalcemia (total calcium of >10.6 mg/dL or ionized serum calcium of >5.4 mg/dL
  • Tuberculosis history or clinical exam
  • Sarcoidosis history or clinical exam
  • Nephrolithiasis within the prior year
  • Patients not deemed suitable for study participation (ie, psychiatric disease, living remotely from the clinic, or prisoner status)
  • Pregnant or nursing women

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Utah Hospital

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

Official title: Randomized Clinical Trial of Hypovitaminosis D Treatment in the Neurocritical Care Unit

Vitamin D has been shown to impact prognosis in a variety of retrospective and randomized clinical trials within an intensive care unit (ICU) environment. Despite these findings, there have been no studies examining the impact of hypovitaminosis D in specialized neurocritical care units (NCCU). Given the often significant differences in the management of patients in NCCU and more generalized intensive care units there is a need for further inquiries into the impact of low vitamin D levels in this specific environment. This study proposes a randomized, double-blinded, placebo-controlled, single center evaluation of vitamin D supplementation in the emergent NCCU patient population. The primary outcome will involve length-of-stay for emergent neurocritical care patients. Various secondary outcomes, including in-hospital mortality, ICU length-of-stay, Glasgow Outcome Score on discharge, complications and quality-of-life metrics. Patients will be followed for 6 months post-discharge.

Read the detailed description

Vitamin D has been shown as an important marker of prognosis in a variety of clinical settings, including overall mortality, acute respiratory distress syndrome (ARDS), infection/sepsis, asthma, cardiovascular disease, diabetes, and pediatric/medical/surgical intensive care unit outcomes. Vitamin D not only plays a role in bone maintenance, but also a variety of extra-axial functions including immune-dysregulation and systemic inflammation. In addition, a number of randomized clinical trials support the supplementation of vitamin D as improving outcome in critical care patients. While the evaluation of vitamin D levels remains a standard-of-care at our institution, the widespread use of vitamin D monitoring and impact on neurocritical care patients remains limited. The investigators' recent prospective observational study of vitamin D levels in neurocritical patients showed that deficiency (<20ng/dL) was highly associated with prolonged hospital stay and increased in-hospital mortality for emergent patients. Moreover, a number of limitations arise from this study due to its observational nature. This study proposes a randomized, double-blinded, placebo-controlled, single center evaluation of vitamin D supplementation in the neurocritical care patient population. Patients admitted to the neurocritical care unit for emergent cases and with vitamin D deficiency (<20ng/dL) will undergo vitamin D serum draw on admission and be randomized to receive cholecalciferol/vitamin D3 supplementation (540,000 IU once orally) or placebo. The primary outcome measured will be hospital length-of-stay. Secondary outcomes will include length of ICU course, complications, medication adverse events, discharge Glasgow Outcome Score, in-hospital and 30-day mortality, as well as quality-of-life. Power analysis estimates 198 patients will be needed for each subgroup to determine a 2 day difference in length-of-stay, and the study plans to recruit 218 patients per treatment arm to account for dropout, which will take approximately 6-9 months to recruit. Interim analysis and safety monitoring will be performed. The investigators hypothesize that vitamin D supplementation may make a significant impact on reducing morbidity and mortality in the neurocritical care population. The possibility of reducing hospital length of stay and mortality from a simple, safe, and cost-effective intervention such as vitamin D supplementation may be a useful adjuvant treatment in the neurocritical care population.

Being tested
Cholecalciferol, Placebo
Keywords
critical illness, craniocerebral trauma, intracranial aneurysm, spinal cord injuries, seizures, meningitis, stroke, vitamin d deficiency, cholecalciferol, intracranial hemorrhages
Medical subject headings
Craniocerebral Trauma, Intracranial Aneurysm, Brain Neoplasms, Spinal Cord Injuries, Seizures, Meningitis, Stroke, Intracranial Hemorrhages

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02881957
Study groupRoleWhat they receive
ControlPlacebo comparatorPlacebo control (simple oral syrup)
Receives: Other: Placebo
Vitamin D3ExperimentalCholecalciferol/Vitamin D3 (540,000 IU orally or by feeding tube once)
Receives: Drug: Cholecalciferol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intent-to-treat Hospital Length-of-stay

    Intent-to-treat hospital length-of-stay

    Measured: Until discharge

  2. As-treated Hospital Length of Stay

    Two-sided t-test evaluated comparing length of stay in vitamin D3 vs. placebo treated patients utilizing patients after randomization, factoring excluded patients (e.g., as-treated) using a p<0.05 as significant.

    Measured: Until discharge

Secondary outcomes (8)

  1. Intent-to-treat ICU Length of Stay

    Two-sided t-test evaluated comparing length of stay within the ICU specifically in vitamin D3 vs. placebo treated patients utilizing patients after randomization (e.g., intent-to-treat) using a p<0.05 as significant.

    Measured: Until discharge

  2. As-treated ICU Length of Stay

    Two-sided t-test evaluated comparing length of stay within the ICU specifically in vitamin D3 vs. placebo treated patients utilizing patients after randomization but excluding patients who did not receive treatment (e.g., as-treated) using a p<0.05 as significant.

    Measured: Until discharge

  3. In-hospital Mortality

    In-hospital mortality

    Measured: Until discharge

  4. Number of Participants With Study Drug Related Adverse Events

    The occurrence of patients who suffered mortality, adverse events or severe adverse events, related specifically to the study drug was monitored. Severe adverse events are defined using common terminology criteria for adverse events (CTCAE) grade 3 or higher specific to vitamin D from time of study drug administration to discharge.

    Measured: Until discharge

  5. Number of Participants With Sepsis

    Diagnosis of sepsis

    Measured: Until discharge

  6. Number of Participants With Pneumonia

    Pneumonia diagnosis

    Measured: Until discharge

  7. Number of Participants With Urinary Tract Infection

    Urinary tract infection diagnosis

    Measured: Until discharge

  8. Number of Participants With Deep Vein Thrombosis

    Deep vein thrombosis diagnosis

    Measured: Until discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2016 (estimated)
  2. Study start10 Oct 2016
  3. Primary completion10 Oct 2018
  4. Study completion10 Oct 2018

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
274 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02881957
Sponsor's protocol ID
IRB_00091541
Status last verified
May 2022
First submitted
24 Aug 2016
Last updated
15 Jun 2022
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Guan J, Karsy M, Brock AA, Eli IM, Ledyard HK, Hawryluk GWJ, Park MS. A prospective analysis of hypovitaminosis D and mortality in 400 patients in the neurocritical care setting. J Neurosurg. 2017 Jul;127(1):1-7. doi: 10.3171/2016.4.JNS16169. Epub 2016 Jul 1.

    PubMed 27367248

  • Carter BS, Barker FG. Editorial. Choices in clinical trial design. J Neurosurg. 2019 Sep 13;133(4):1100-1102. doi: 10.3171/2019.7.JNS183276. Print 2020 Oct 1. No abstract available.

    PubMed 31518987

  • Karsy M, Guan J, Eli I, Brock AA, Menacho ST, Park MS. The effect of supplementation of vitamin D in neurocritical care patients: RandomizEd Clinical TrIal oF hYpovitaminosis D (RECTIFY). J Neurosurg. 2019 Sep 13;133(4):1103-1112. doi: 10.3171/2018.11.JNS182713. Print 2020 Oct 1.

    PubMed 31518978

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cholecalciferol in people with Craniocerebral Trauma and Intracranial Aneurysm, run by University of Utah at 1 site in United States.

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 6 inclusion and 14 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 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Intent-to-treat Hospital Length-of-stay (time frame: Until discharge). The study lists 2 primary outcomes in all. 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 NCT02881957, which also lists 3 linked publications.

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 15 Jun 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in