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Kidney CalculiNCT05081960

Evaluating the Vitamin K2 Status of Calcium-based Stone Formers

An observational study of Kidney Calculi and Calcium Oxalate Kidney Stones, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Completed

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

Official record
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Trial summary

This is an observation, single site-study with one study visit during which all data and samples will be collected. Study participants will be asked to provide blood, urine, and fecal samples so that the investigators may study the differences in the gut microbiota, vitamin K2 levels, and other parameters between… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
How many people
60 participants
Where
1 siteCanada
Study dates
1 Aug 2022to 8 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Stone formers will be recruited from the Urology clinic or London and surrounding community. Controls will be recruited from the London and surrounding community.

Who may be able to join

  • Male/Female, 18 - 65 years old
  • 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

Who cannot join

  • Current, or within 30 days, use of antibiotics or antifungals
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Joseph's Health Care London

    London, Ontario, N6J 3T9

Other trials in Canada

About this study

This is an observation, single site-study with one study visit during which all data and samples will be collected. Study participants will be asked to provide blood, urine, and fecal samples so that the investigators may study the differences in the gut microbiota, vitamin K2 levels, and other parameters between participants who form kidney stones and those who do not.

Read the detailed description

It is hypothesized that calcium-based stone formers will have an altered fecal gut microbiota compared to non-stone former controls. This altered microbiota will have a lower abundance of bacteria that produce menaquinones (vitamin K2), thus stone formers will also have a different blood menaquinone profile compared to controls. Ultimately, the different levels of menaquinones will result in increased inactive Matrix Gla protein (dp-ucMGP), which is a key protein that sequesters free calcium. To test this hypothesis, calcium-based stone former and non-stone forming controls will be recruited to a single site, observation study to collect urine, blood, and fecal samples. These samples will be used to determine dp-ucMGP levels, menaquinone profiles, the composition of the gut microbiota, and other parameters of interest.

Keywords
Kidney stone disease, Microbiota, Menaquinone, Vitamin K2, Matrix Gla protein, dp-ucMGP, Nephrolithiasis
Medical subject headings
Kidney Calculi, Nephrolithiasis, Calcium Oxalate, Nephrolithiasis

What participants receive

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

Study groups in NCT05081960
Study groupRoleWhat they receive
Stone FormersIndividuals who have experienced at least one incidence of calcium-based kidney stones in the last 12 months
ControlsIndividuals who have never had a kidney stone in their lifetime.

What is being measured

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

  1. Fecal microbiota composition of stone-formers and controls

    Fecal samples will be collected using out validated toilet paper method. Microbial DNA will be extracted and sequenced using next-generation sequencing.

    Measured: At baseline only

  2. Concentration of urine dp-ucMGP (dephosphorylated-uncarboxylated Matrix Gla Protein)

    dp-ucMGP will be quantified using an enzyme-linked immunosorbent assay

    Measured: At baseline only

  3. Concentration of blood dp-ucMGP (dephosphorylated-uncarboxylated Matrix Gla Protein)

    dp-ucMGP will be quantified using an enzyme-linked immunosorbent assay

    Measured: At baseline only

  4. Concentration of blood total osteocalcin (OC)

    Total OC will be quantified using an enzyme-linked immunosorbent assay

    Measured: At baseline only

  5. Concentration of blood undercarboxylated osteocalcin (ucOC)

    ucOC will be quantified using an enzyme-linked immunosorbent assay

    Measured: At baseline only

  6. Concentration of urine total osteocalcin (OC)

    Total OC will be quantified using an enzyme-linked immunosorbent assay

    Measured: At baseline only

  7. Concentration of urine undercarboxylated osteocalcin (ucOC)

    ucOC will be quantified using an enzyme-linked immunosorbent assay

    Measured: At baseline only

  8. Concentration of blood menaquinones (vitamin K2) - MK-4

    Menaquinones will be quantified using liquid chromatography with mass spectrometry or fluorescence.

    Measured: At baseline only

  9. Concentration of blood menaquinones (vitamin K2) - MK-7

    Menaquinones will be quantified using liquid chromatography with mass spectrometry or fluorescence.

    Measured: At baseline only

  10. Concentration of blood menaquinones (vitamin K2) - MK-8

    Menaquinones will be quantified using liquid chromatography with mass spectrometry or fluorescence.

    Measured: At baseline only

  11. Concentration of blood menaquinones (vitamin K2) - MK-9

    Menaquinones will be quantified using liquid chromatography with mass spectrometry or fluorescence.

    Measured: At baseline only

  12. Concentration of blood menaquinones (vitamin K2) - MK-10

    Menaquinones will be quantified using liquid chromatography with mass spectrometry or fluorescence.

    Measured: At baseline only

  13. Concentration of blood menaquinones (vitamin K2) - MK-11

    Menaquinones will be quantified using liquid chromatography with mass spectrometry or fluorescence.

    Measured: At baseline only

  14. Concentration of blood menaquinones (vitamin K2) - MK-12

    Menaquinones will be quantified using liquid chromatography with mass spectrometry or fluorescence.

    Measured: At baseline only

  15. Concentration of blood menaquinones (vitamin K2) - MK-13

    Menaquinones will be quantified using liquid chromatography with mass spectrometry or fluorescence.

    Measured: At baseline only

Secondary outcomes (10)

  1. Concentration of blood fetuin A

    Fetuin A will be quantified using enzyme-linked immunosorbent assay

    Measured: At baseline only

  2. Concentration of urine fetuin A

    Fetuin A will be quantified using enzyme-linked immunosorbent assay

    Measured: At baseline only

  3. Percentage of blood Hemoglobin A1C (HbA1c)

    HbA1c will be quantified in the core laboratory as per established protocols

    Measured: At baseline only

  4. Total plasma calcium

    Calcium levels will be quantified in the core laboratory

    Measured: At baseline only

  5. Concentration of ionized calcium in blood

    Calcium levels will be quantified in the core laboratory

    Measured: At baseline only

  6. Concentration of blood albumin

    Albumin levels will be quantified in the core laboratory as per established protocols

    Measured: At baseline only

  7. Concentration of urinary γ-carboxyglutamic acid

    γ-carboxyglutamic acid will be quantified using high-performance liquid chromatography and normalized to creatinine

    Measured: At baseline only

  8. Concentration of urinary creatinine

    Creatinine will be quantified using high-performance liquid chromatography

    Measured: At baseline only

  9. Concentration of urinary oxalate

    Oxalate will be quantified using high-performance liquid chromatography and normalized to creatinine

    Measured: At baseline only

  10. Concentration of urinary phosphate

    Phosphate will be quantified in the core laboratory as per established protocols

    Measured: At baseline only

Timeline

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

  1. First posted18 Oct 2021
  2. Study start1 Aug 2022
  3. Primary completion8 Jun 2023
  4. Study completion8 Jun 2025

Resources

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
Case-control
Time perspective
Cross-sectional
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05081960
Sponsor's protocol ID
119537
Status last verified
Aug 2024
First submitted
22 Sep 2021
Last updated
22 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 3042764

  • Moe OW. Kidney stones: pathophysiology and medical management. Lancet. 2006 Jan 28;367(9507):333-44. doi: 10.1016/S0140-6736(06)68071-9.

    PubMed 16443041

  • 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.

    PubMed 32503496

  • 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.

    PubMed 37161031

  • 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.

    PubMed 7895417

  • 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.

    PubMed 23140417

  • 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.

    PubMed 22498635

  • 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.

    PubMed 11356998

  • 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.

    PubMed 11960685

  • 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.

    PubMed 28340119

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Calculi and Calcium Oxalate Kidney Stones, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 7 inclusion and 6 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 22 Jul 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Fecal microbiota composition of stone-formers and controls (time frame: At baseline only). The study lists 15 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 NCT05081960, which also lists 10 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 22 Jul 2025.

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