Acute Kidney InjuriesVITALNCT06688994
Vitamin D Metabolites as Biomarkers for the Identification of Kidney Injury in Cardiac Surgery
An observational study of Acute Kidney Injuries and Chronic Renal Diseases, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The investigators will be measuring vitamin D metabolites in blood samples drawn from patients undergoing cardiac surgery to determine the correlation with renal function as assessed by serum creatinine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injuries, Chronic Renal Diseases
- How many people
- 46 participants
- Where
- 1 siteCanada
- Study dates
- 2 Dec 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients undergoing cardiac surgery .
Who may be able to join
- ≥ 18 years
- Patients undergoing cardiac surgery
- Serum Creatinine measured with 28 days of surgery
Who cannot join
- Exogeneous calcitriol (1,25(OH)2D3) intake
- History of parathyroidectomy
- Patients with liver or kidney cancer
- Patients with liver disease (e.g. liver failure, cirrhosis)
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network-Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
The investigators will be measuring vitamin D metabolites in blood samples drawn from patients undergoing cardiac surgery to determine the correlation with renal function as assessed by serum creatinine. The investigators will include 20 patients in each of the following 3 groups based on serum creatinine measured within 28-days of surgery: 1) normal kidney function (eGFR > 60 mL/min, n=20), 2) moderate impaired kidney function, eGFR between 30 and 60 mL/min (n=20) and 3) severe kidney dysfunction eGFR < 30 mL/min (n=20).
- Conditions
- Acute Kidney Injuries, Chronic Renal Diseases
- Keywords
- Chronic renal disease, Acute kidney injury, Vitamin D
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the correlation between eGFR as determined serum creatinine and vitamin D metabolites as markers of kidney function
serum creatinine (sCr) and vitamin D metabolites (specifically 25(OH)D3 and 1,25(OH)2D3) will be measured in the same blood sample to determine the incidence of AKI and CKD in patients undergoing cardiac surgery
Measured: Up to 1 month before surgery up until POD 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start2 Dec 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuriesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Sponsor
- Investigators
- Stuart A McCluskey, MD, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688994
- Sponsor's protocol ID
- 23-6027
- Acronym
- VITAL
- Status last verified
- Jan 2026
- First submitted
- 12 Nov 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data from this study is unique to the study and analytical techniques used
Publications
Chow EC, Quach HP, Vieth R, Pang KS. Temporal changes in tissue 1alpha,25-dihydroxyvitamin D3, vitamin D receptor target genes, and calcium and PTH levels after 1,25(OH)2D3 treatment in mice. Am J Physiol Endocrinol Metab. 2013 May 1;304(9):E977-89. doi: 10.1152/ajpendo.00489.2012. Epub 2013 Mar 12.
PubMed 23482451Chow EC, Sondervan M, Jin C, Groothuis GM, Pang KS. Comparative effects of doxercalciferol (1alpha-hydroxyvitamin D(2)) versus calcitriol (1alpha,25-dihydroxyvitamin D(3)) on the expression of transporters and enzymes in the rat in vivo. J Pharm Sci. 2011 Apr;100(4):1594-604. doi: 10.1002/jps.22366. Epub 2010 Oct 21.
PubMed 20967888
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Metabolites as Biomarkers for the Identification of Kidney Injury in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06688994
- Acronym / sponsor ID
- VITAL / 23-6027
- Conditions
- Acute Kidney Injuries, Chronic Renal Diseases
- Keywords
- Chronic renal disease, Acute kidney injury, Vitamin D
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Nov 2024 (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.
The investigators will be measuring vitamin D metabolites in blood samples drawn from patients undergoing cardiac surgery to determine the correlation with renal function as assessed by serum creatinine. The investigators will include 20 patients in each of the following 3 groups based on serum creatinine measured within 28-days of surgery: 1) normal kidney function (eGFR > 60 mL/min, n=20), 2) moderate impaired kidney function, eGFR between 30 and 60 mL/min (n=20) and 3) severe kidney dysfunction eGFR < 30 mL/min (n=20).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery .
Key inclusion criteria (3 listed)
- ≥ 18 years
- Patients undergoing cardiac surgery
- Serum Creatinine measured with 28 days of surgery
Key exclusion criteria (4 listed)
- Exogeneous calcitriol (1,25(OH)2D3) intake
- History of parathyroidectomy
- Patients with liver or kidney cancer
- Patients with liver disease (e.g. liver failure, cirrhosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the correlation between eGFR as determined serum creatinine and vitamin D metabolites as markers of kidney function
Time frame: Up to 1 month before surgery up until POD 7
serum creatinine (sCr) and vitamin D metabolites (specifically 25(OH)D3 and 1,25(OH)2D3) will be measured in the same blood sample to determine the incidence of AKI and CKD in patients undergoing cardiac surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Results publication: PubMed 23482451Chow EC, Quach HP, Vieth R, Pang KS. Temporal changes in tissue 1alpha,25-dihydroxyvitamin D3, vitamin D receptor target genes, and calcium and PTH levels after 1,25(OH)2D3 treatment in mice. Am J Physiol Endocrinol Metab. 2013 May 1;304(9):E977-89. doi: 10.1152/ajpendo.00489.2012. Epub 2013 Mar 12.
- Results publication: PubMed 20967888Chow EC, Sondervan M, Jin C, Groothuis GM, Pang KS. Comparative effects of doxercalciferol (1alpha-hydroxyvitamin D(2)) versus calcitriol (1alpha,25-dihydroxyvitamin D(3)) on the expression of transporters and enzymes in the rat in vivo. J Pharm Sci. 2011 Apr;100(4):1594-604. doi: 10.1002/jps.22366. Epub 2010 Oct 21.
- Individual participant dataSharing planned: No. Data from this study is unique to the study and analytical techniques used
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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.
Stuart A McCluskey, MD, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injuries and Chronic Renal Diseases, run by University Health Network, Toronto at 1 site in Canada.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Determine the correlation between eGFR as determined serum creatinine and vitamin D metabolites as markers of kidney function (time frame: Up to 1 month before surgery up until POD 7). 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 NCT06688994, which also lists 2 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 3 Feb 2026.