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Evaluating the Vitamin K2 Status of Calcium-based Stone Formers

Sponsored by Lawson Health Research Institute

About this trial

Last updated 2 years ago

Study ID

119537

Status

Active, not recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
18 to 65 Years
All
All

Trial Timing

Ended 2 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- 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

No

Exclusion Criteria

- 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.

Locations

Location

Status