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

NCT ID: NCT01735461

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2023-12-31

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.

Conditions

Kidney Calculi; Crohn's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dietary supplement

Calcium Carbonate

Group Type: EXPERIMENTAL

Calcium Carbonate

Intervention Type: DIETARY_SUPPLEMENT

There is a regimen for dietary supplement intake that will be provided to study participants.

Interventions

Calcium Carbonate

There is a regimen for dietary supplement intake that will be provided to study participants.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

CaCO3

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Ben Chew, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ben Chew, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Olga Arsovska

Role: CONTACT

olga.arsovska@ubc.ca

6048754111 ext. 62421

Other Identifiers

H11-02525

Identifier Type: -

Identifier Source: org_study_id