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

Primary Purpose

Kidney Calculi, Crohn's Disease

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Calcium Carbonate
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Calculi

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vancouver General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dietary supplement

Arm Description

Calcium Carbonate

Outcomes

Primary Outcome Measures

Molar ratio of urinary calcium:oxalate in relation to the supersaturation product of calcium oxalate
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 7 days and then we will evaluate their urine chemistry. 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.

Secondary Outcome Measures

Optimal level of Ca supplementation for prevention of stones in Crohn's patients
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.

Full Information

First Posted
November 22, 2012
Last Updated
May 16, 2022
Sponsor
University of British Columbia
Collaborators
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01735461
Brief Title
Calcium Supplements Strategy for Kidney Stones Prevention in Crohn's Patients
Official Title
Oral Calcium Supplementation, a Strategy to Reduce Kidney Stones in Crohn's Patients Living With a Small Bowel Resection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Calculi, Crohn's Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dietary supplement
Arm Type
Experimental
Arm Description
Calcium Carbonate
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium Carbonate
Other Intervention Name(s)
CaCO3
Intervention Description
There is a regimen for dietary supplement intake that will be provided to study participants.
Primary Outcome Measure Information:
Title
Molar ratio of urinary calcium:oxalate in relation to the supersaturation product of calcium oxalate
Description
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 7 days and then we will evaluate their urine chemistry. 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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Optimal level of Ca supplementation for prevention of stones in Crohn's patients
Description
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.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olga Arsovska
Phone
6048754111
Ext
62421
Email
olga.arsovska@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Chew, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ben Chew, MD
First Name & Middle Initial & Last Name & Degree
Ryan Paterson, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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