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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by University of British Columbia
Sponsor:
Collaborator:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01735461
First received: November 22, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted

November 22, 2012
November 22, 2012
December 2012
September 2015   (final data collection date for primary outcome measure)
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.

Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
Calcium Supplements Strategy for Kidney Stones Prevention in Crohn's Patients
Oral Calcium Supplementation, a Strategy to Reduce Kidney Stones in Crohn's Patients Living With a Small Bowel Resection

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Kidney Calculi
  • Crohn's Disease
Dietary Supplement: Calcium Carbonate
There is a regimen for dietary supplement intake that will be provided to study participants.
Other Name: CaCO3
Experimental: Dietary supplement
Calcium Carbonate
Intervention: Dietary Supplement: Calcium Carbonate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
December 2015
September 2015   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact: Olga Arsovska 6048754111 ext 62421 olga.arsovska@ubc.ca
Canada
 
NCT01735461
H11-02525
Yes
University of British Columbia
University of British Columbia
University of Texas Southwestern Medical Center
Principal Investigator: Ben Chew, MD University of British Columbia
University of British Columbia
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP