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

NCT01735461 | Unknown DMC

• 1 other identifier: H11-02525
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Calculi; Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  7 days

Study Arms (1)

Dietary supplement

EXPERIMENTAL

Calcium Carbonate

Dietary Supplement: Calcium Carbonate

Interventions

Calcium Carbonate DIETARY_SUPPLEMENT

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

Also known as: CaCO3

Dietary supplement

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• University of Texas Southwestern Medical Center: collaborator

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

RECRUITING

MeSH Terms

Conditions

Kidney Calculi; Crohn Disease

Interventions

Calcium Carbonate

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Ben Chew, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Arsovska

CONTACT

6048754111; olga.arsovska@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 22, 2012
• First Posted: November 28, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)