A Phase 2/3 interventional study of Cholecalciferol and Placebo in Craniocerebral Trauma, Intracranial Aneurysm and Brain Neoplasms, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-15.
Sponsored by University of Utah · Phase 2/3, Interventional, and Treatment
Among 95 studies in Craniocerebral Trauma with a site in United States — 12 open to participants now, 17 under way, none of them phase 3. Craniocerebral Trauma · United States.
Among the 95 studies in Craniocerebral Trauma with a site in United States, this one is the 14th largest by enrollment of the 61 interventional ones, is one of 5 that started in 2016, is the only one in phase 2/3, and was the 49th registered.
253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.
This study's enrollment of 274 is above the median of 87 across 133 interventional studies indexed under Craniocerebral Trauma.
Browse Craniocerebral Trauma studies →12 of the 95 studies in Craniocerebral Trauma with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 25 Craniocerebral Trauma studies recruiting now, 8 (32%) set no upper age limit and 14 (56%) stop at 75 or younger; 8 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →95 studies; the count open now beside each. This study's row is marked.
First in 1983; this study’s year is marked. 5 started in 2016.
Median enrollment 94 across the 61 interventional studies, 192 across the 33 observational. Of the 69 that completed or were terminated, 17 (25%) have results posted.
9 of 95 have an industry lead sponsor. The 10 most frequent:
University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.
University of Utah has 2 studies filed under Craniocerebral Trauma — fewer than ten, so there is no comparison to draw.
3 of the studies in Craniocerebral Trauma with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06632587Thomas Jefferson UniversityTiming Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes | 2026-12-01 |
| NCT06697808Wake Forest University Health SciencesCranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics | 2027-04 |
| NCT05663034Johns Hopkins UniversityCBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms | 2027-06 |
Among the 95 studies in Craniocerebral Trauma with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo control (simple oral syrup)
Other: Placebo
Cholecalciferol/Vitamin D3 (540,000 IU orally or by feeding tube once)
Drug: Cholecalciferol
Also known as: vitamin D3
Oral syrup placebo
Intent-to-treat Hospital Length-of-stay
Intent-to-treat hospital length-of-stay
Time frame: Until discharge
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.
Time frame: Until discharge
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.
Time frame: Until discharge
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.
Time frame: Until discharge
In-hospital Mortality
In-hospital mortality
Time frame: Until discharge
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.
Time frame: Until discharge
Number of Participants With Sepsis
Diagnosis of sepsis
Time frame: Until discharge
Number of Participants With Pneumonia
Pneumonia diagnosis
Time frame: Until discharge
Number of Participants With Urinary Tract Infection
Urinary tract infection diagnosis
Time frame: Until discharge
Number of Participants With Deep Vein Thrombosis
Deep vein thrombosis diagnosis
Time frame: Until discharge
| Milestone | Placebo | Vitamin D3 |
|---|---|---|
| Started | 136 | 138 |
| Completed | 133 | 134 |
| Not completed | 3 | 4 |
| Withdrew: Comfort care | 0 | 1 |
| Withdrew: Concurrent trial enrollment | 0 | 1 |
| Withdrew: Discharged within 48 hours | 0 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
Intent-to-treat hospital length-of-stay
| days | Vitamin D3 | Placebo |
|---|---|---|
| Intent-to-treat Hospital Length-of-stay | 10.9 ± 15.6 | 9.1 ± 7.9 |
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.
| days | Vitamin D3 | Placebo |
|---|---|---|
| As-treated Hospital Length of Stay | 10.4 ± 14.5 | 9.1 ± 7.9 |
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.
| days | Vitamin D3 | Placebo |
|---|---|---|
| Intent-to-treat ICU Length of Stay | 6.4 ± 9.8 | 5.4 ± 6.4 |
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.
| days | Vitamin D3 | Placebo |
|---|---|---|
| As-treated ICU Length of Stay | 5.8 ± 7.5 | 5.4 ± 6.4 |
In-hospital mortality
| Participants | Vitamin D3 | Placebo |
|---|---|---|
| In-hospital Mortality | 11 | 13 |
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.
| Participants | Vitamin D3 | Placebo |
|---|---|---|
| Number of Participants With Study Drug Related Adverse Events | 0 | 0 |
Diagnosis of sepsis
| Participants | Vitamin D3 | Placebo |
|---|---|---|
| Number of Participants With Sepsis | 2 | 3 |
Pneumonia diagnosis
| Participants | Vitamin D3 | Placebo |
|---|---|---|
| Number of Participants With Pneumonia | 16 | 14 |
Urinary tract infection diagnosis
| Participants | Vitamin D3 | Placebo |
|---|---|---|
| Number of Participants With Urinary Tract Infection | 9 | 6 |
Deep vein thrombosis diagnosis
| Participants | Vitamin D3 | Placebo |
|---|---|---|
| Number of Participants With Deep Vein Thrombosis | 8 | 3 |
Collected over Adverse events were monitored until patient discharge from the hospital.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vitamin D3 | 11/134 (8.2%) | 0/134 (0%) | 0/134 (0%) |
| Placebo | 13/133 (9.8%) | 0/133 (0%) | 0/133 (0%) |
| Age, Continuous(years) | Vitamin D3 | Placebo | Total |
|---|---|---|---|
| Mean | 52.9 ± 17.5 | 55.1 ± 16.8 | 54.0 ± 17.2 |
| Sex: Female, Male(Participants) | Vitamin D3 | Placebo | Total |
|---|---|---|---|
| Female | 56 | 59 | 115 |
| Male | 78 | 74 | 152 |
| Ethnicity (NIH/OMB)(Participants) | Vitamin D3 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 15 | 25 |
| Not Hispanic or Latino | 114 | 102 | 216 |
| Unknown or Not Reported | 10 | 16 | 26 |
| Race (NIH/OMB)(Participants) | Vitamin D3 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 4 | 5 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 1 | 3 | 4 |
| Black or African American | 5 | 3 | 8 |
| White | 107 | 99 | 206 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 18 | 23 | 41 |
| Region of Enrollment(Participants) | Vitamin D3 | Placebo | Total |
|---|---|---|---|
| United States | 134 | 133 | 267 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2016 to primary completion in Oct 2018, 24 months.
Results were first posted in Aug 2020, 1 year 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholecalciferol