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

Sponsor

University of British Columbia (Other)

Overall Status

Recruiting

CT.gov ID

NCT01735461

Collaborator

University of Texas Southwestern Medical Center (Other)

Enrollment

Location

Arm

132

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Calculi Crohn's Disease	Dietary Supplement: Calcium Carbonate	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Dec 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Molar ratio of urinary calcium:oxalate in relation to the supersaturation product of calcium oxalate [7 days]
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 [7 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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