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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Calculi; Crohn's Disease
• Intervention / Treatment: Dietary supplement: Calcium Carbonate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olga Arsovska; Phone Number: 62421 6048754111; Email: olga.arsovska@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z1M9
      • Recruiting
      • Vancouver General Hospital
      • Principal Investigator: Ben Chew, MD
      • Sub-Investigator: Ryan Paterson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: CaCO3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 22, 2012
• First Submitted That Met QC Criteria: November 22, 2012
• First Posted (Estimate): November 28, 2012

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Kidney Diseases; Urologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Pathological Conditions, Anatomical; Inflammatory Bowel Diseases; Urolithiasis; Urinary Calculi; Crohn Disease; Calculi; Kidney Calculi; Nephrolithiasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Calcium-Regulating Hormones and Agents; Antacids; Calcium; Calcium Carbonate
• Other Study ID Numbers: H11-02525

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No