Recruiting

Calcium Supplements

Sponsor:

University of British Columbia

Code:

NCT01735461

Conditions

Kidney Calculi

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Calcium Carbonate

Study Details

Brief summary:

Hospitalization for kidney stones in the Inflammatory Bowel Disease (IBD) population is common, particularly among Crohn's patients who had a small bowel resection. This patient population experiences a lifetime occurrence of kidney stone formation as high as 25% accompanied with a high rate of recurrence (the typical rate of stone formation is \~10% in the non IBD population). Giving oral calcium is used to bind oxalate in the intestine in an attempt to reduce the amount of oxalate that is absorbed into the body and to reduce urinary oxalate levels. However, there are no defined guidelines for the optimum dosing of calcium. This study's primary objective is to scientifically define an appropriate range of calcium supplementation that reduce the level of oxalate found in the urine of patients living with inflammatory bowel disease.

Conditions

Kidney Calculi

Crohn's Disease

Study ID

NCT01735461

Start date

Dec, 2012

Status verified date

May, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. a pathologically confirmed diagnosis of Crohn's disease
2. prior ileal resection with an intact colon (surgery>6 months preceding involvement in study)
3. hyperoxaluria (defined as> 48 mg (>0.5 mmol) per 24 hour urine samples.

  • Patients will not be excluded if they are known kidney stone formers.

Exclusion Criteria:

1. current pregnancy
2. patient's without baseline hyperoxaluria (defined as >48 mg or 0.5mmol per 24 hour urine samples)
3. patients in renal failure assessed by a GFR < 60
4. inability to provide informed consent
5. active cancer
6. hyperparathyroidism
7. hyperphosphatemia
8. <19 years of age

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Dietary supplement

Calcium Carbonate

Interventions

Calcium Carbonate

There is a regimen for dietary supplement intake that will be provided to study participants.

Primary outcome measure

  • Molar ratio of urinary calcium:oxalate in relation to the supersaturation product of calcium oxalate [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z1M9

Principal Investigator:

Ben Chew, MD

More Information

Sponsor

University of British Columbia

Last update posted

May 17, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of British Columbia on 2022-05-17.