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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Oral Calcium Supplementation, a Strategy to Reduce Kidney Stones in Crohn's Patients Living With a Small Bowel Resection

Conditions
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Kidney Calculi, Crohn's Disease

Intervention / Treatment
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* Dietary Supplement: Calcium Carbonate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary supplement<br>Calcium Carbonate | Dietary Supplement: Calcium Carbonate<br>* There is a regimen for dietary supplement intake that will be provided to study participants.<br>* Other names: CaCO3;|

What is the study measuring?
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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 |