Calcium Supplements Strategy for Kidney Stones Prevention in Crohn's Patients
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Oral Calcium Supplementation, a Strategy to Reduce Kidney Stones in Crohn's Patients Living With a Small Bowel Resection|
- Molar ratio of urinary calcium:oxalate in relation to the supersaturation product of calcium oxalate [ Time Frame: 4 days for each of the 3 doses of Ca supplement ] [ Designated as safety issue: No ]
Molar ratio of urinary calcium:oxalate in relation to the supersaturation product of calcium oxalate will be calculated from the 24-hour urine test.
The patient will take dietary calcium for 4 days and then we will evaluate their urine chemistry. Previous studies indicate 4 days is an acceptable period to allow for metabolic and urinary equilibration of calcium. Additionally, 24-hour urine collections are considered the standard for urinalysis in comparison to spot urine chemistry. The initial data, prior to calcium supplementation, will serve as the control, providing the patient's baseline risk for kidney stone formation.
- Optimal level of Ca supplementation for prevention of stones in Crohn's patients [ Time Frame: 4 days for each of the 3 doses for Ca supplements ] [ Designated as safety issue: No ]Practical guidelines for physicians managing Crohn's patients will be developed based on the optimal Ca supplement dosages and determine the optimal level of calcium supplementation in each patient, based on urinary parameters from 24-hour urine.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: Dietary supplement
Dietary Supplement: Calcium Carbonate
There is a regimen for dietary supplement intake that will be provided to study participants.
Other Name: CaCO3
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735461
|Contact: Olga Arsovska||6048754111 ext email@example.com|
|Canada, British Columbia|
|Vancouver General Hospital||Not yet recruiting|
|Vancouver, British Columbia, Canada, V5Z1M9|
|Principal Investigator: Ben Chew, MD|
|Sub-Investigator: Ryan Paterson, MD|
|Principal Investigator:||Ben Chew, MD||University of British Columbia|