Calcium Supplements Strategy for Kidney Stones Prevention in Crohn's Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 19 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01735461
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of British Columbia
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ben Chew, MD
Principal Investigator Affiliation University of British Columbia
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Kidney Calculi, Crohn's Disease
Additional Details

The primary objective of this study is to establish optimal oral calcium supplementation in Crohn's patients who have had an ileal bowel resection. This population is at high risk for calcium oxalate kidney stones, a direct consequence of extensive gut malabsorption and enteric hyperoxaluria. The benefit of providing oral calcium in this patient population (as a means to reduce intestinal oxalate absorption) is known, however, there are no appropriate targets for calcium dosing, which is presently performed empirically or not at all. Our goal is to establish simple, safe and practical guidelines for calcium supplementation.

Arms & Interventions

Arms

Experimental: Dietary supplement

Calcium Carbonate

Interventions

Dietary Supplement: - Calcium Carbonate

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

Contact a Trial Team

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International Sites

Vancouver General Hospital, Vancouver, British Columbia, Canada

Status

Recruiting

Address

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9

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