Evaluating the Vitamin K2 Status of Calcium-based Stone Formers
NCT ID: NCT05081960
Last Updated: 2025-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
60 participants
OBSERVATIONAL
2022-08-01
2025-06-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Urine and Stool Analysis in Kidney Stone Disease
NCT01637506
Bacterial Analysis of Kidney Stones Removed by Percutaneous Nephrolithotomy
NCT02739919
Empiric Versus Selective Prevention Strategies for Kidney Stone Disease
NCT05365477
Evaluation of Pain Before and After Removal of Non-obstructive Kidney Stones
NCT03657667
Proteomic Study of Urinary Stone Disease
NCT00199459
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stone Formers
Individuals who have experienced at least one incidence of calcium-based kidney stones in the last 12 months
No interventions assigned to this group
Controls
Individuals who have never had a kidney stone in their lifetime.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* No self-reported kidney stones during their lifetime (controls)
* Ultrasound examination confirming absence of kidney stones (controls)
* Have had at least 1 incidence of a clinically confirmed calcium-based kidney stone in the last 12 months (stone formers)
* Ability to collect a clean catch urine sample
* Prescription and over-the-counter drugs unchanged for ≥30 days
* Willingness to provide medical information, blood, urine, and fecal samples
Exclusion Criteria
* Current, or within 30 days, use of vitamin K antagonists
* Current probiotic use or any use within 14 days of screening sample collection should be recorded
* A history or currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy 2021-06-29 1.0 Page 4 of 6
* Fecal incontinence
* History of disorder with abnormal calcium regulation such as hyperparathyroidism, active malignancy, or osteoporosis.
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
St. Joseph's Health Care London
OTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jennifer Bjazevic
Principal Investigator, MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jennifer Bjazevic, MD
Role: PRINCIPAL_INVESTIGATOR
Lawson Heath Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Joseph's Health Care London
London, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Conly J, Stein K. Reduction of vitamin K2 concentrations in human liver associated with the use of broad spectrum antimicrobials. Clin Invest Med. 1994 Dec;17(6):531-9.
Fraser JD, Price PA. Lung, heart, and kidney express high levels of mRNA for the vitamin K-dependent matrix Gla protein. Implications for the possible functions of matrix Gla protein and for the tissue distribution of the gamma-carboxylase. J Biol Chem. 1988 Aug 15;263(23):11033-6.
Moe OW. Kidney stones: pathophysiology and medical management. Lancet. 2006 Jan 28;367(9507):333-44. doi: 10.1016/S0140-6736(06)68071-9.
Sato T, Schurgers LJ, Uenishi K. Comparison of menaquinone-4 and menaquinone-7 bioavailability in healthy women. Nutr J. 2012 Nov 12;11:93. doi: 10.1186/1475-2891-11-93.
Scales CD Jr, Smith AC, Hanley JM, Saigal CS; Urologic Diseases in America Project. Prevalence of kidney stones in the United States. Eur Urol. 2012 Jul;62(1):160-5. doi: 10.1016/j.eururo.2012.03.052. Epub 2012 Mar 31.
Schurgers LJ, Vermeer C. Determination of phylloquinone and menaquinones in food. Effect of food matrix on circulating vitamin K concentrations. Haemostasis. 2000 Nov-Dec;30(6):298-307. doi: 10.1159/000054147.
Schurgers LJ, Vermeer C. Differential lipoprotein transport pathways of K-vitamins in healthy subjects. Biochim Biophys Acta. 2002 Feb 15;1570(1):27-32. doi: 10.1016/s0304-4165(02)00147-2.
Stanford J, Charlton K, Stefoska-Needham A, Ibrahim R, Lambert K. The gut microbiota profile of adults with kidney disease and kidney stones: a systematic review of the literature. BMC Nephrol. 2020 Jun 5;21(1):215. doi: 10.1186/s12882-020-01805-w.
Wei FF, Thijs L, Zhang ZY, Jacobs L, Yang WY, Salvi E, Citterio L, Cauwenberghs N, Kuznetsova T, E A Drummen N, Hara A, Manunta P, Li Y, Verhamme P, Allegaert K, Cusi D, Vermeer C, Staessen JA. The risk of nephrolithiasis is causally related to inactive matrix Gla protein, a marker of vitamin K status: a Mendelian randomization study in a Flemish population. Nephrol Dial Transplant. 2018 Mar 1;33(3):514-522. doi: 10.1093/ndt/gfx014.
Chmiel JA, Stuivenberg GA, Al KF, Akouris PP, Razvi H, Burton JP, Bjazevic J. Vitamins as regulators of calcium-containing kidney stones - new perspectives on the role of the gut microbiome. Nat Rev Urol. 2023 Oct;20(10):615-637. doi: 10.1038/s41585-023-00768-5. Epub 2023 May 9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
119537
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.