Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||19 Years and Over|
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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of British Columbia|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Ben Chew, MD|
|Principal Investigator Affiliation||University of British Columbia|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Kidney Calculi, Crohn's Disease|
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.
Experimental: Dietary supplement
Dietary Supplement: - Calcium Carbonate
There is a regimen for dietary supplement intake that will be provided to study participants.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.