Calcium Supplements Strategy for Kidney Stones Prevention in Crohn's Patients
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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.
| Condition | Intervention |
|---|---|
|
Kidney Calculi Crohn's Disease |
Dietary Supplement: Calcium Carbonate |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 40 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dietary supplement
Calcium Carbonate
|
Dietary Supplement: Calcium Carbonate
There is a regimen for dietary supplement intake that will be provided to study participants.
Other Name: CaCO3
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- a pathologically confirmed diagnosis of Crohn's disease
- prior ileal resection with an intact colon (surgery>6 months preceding involvement in study)
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:
- current pregnancy
- patient's without baseline hyperoxaluria (defined as >48 mg or 0.5mmol per 24 hour urine samples)
- patients in renal failure assessed by a GFR < 60
- inability to provide informed consent
- active cancer
- hyperparathyroidism
- hyperphosphatemia
- <19 years of age
Contacts and Locations| Contact: Olga Arsovska | 6048754111 ext 62421 | olga.arsovska@ubc.ca |
| 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 |
More Information
No publications provided
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT01735461 History of Changes |
| Other Study ID Numbers: | H11-02525 |
| Study First Received: | November 22, 2012 |
| Last Updated: | November 22, 2012 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Calculi Crohn Disease Kidney Calculi Nephrolithiasis Pathological Conditions, Anatomical Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Kidney Diseases |
Urologic Diseases Urolithiasis Urinary Calculi Calcium, Dietary Calcium Carbonate Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Antacids Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013