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| Tracking Information | |||||||||
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| First Received Date ICMJE | January 11, 2006 | ||||||||
| Last Updated Date | May 25, 2006 | ||||||||
| Start Date ICMJE | January 2006 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Change in serum potassium on spironolactone versus off of it | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00276289 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics | ||||||||
| Official Title ICMJE | Spironolactone to Decrease Potassium Wasting in Hypercalciuric Patients Treated With Thiazide Diuretics | ||||||||
| Brief Summary | Kidney stone formation due to an excess of calcium in the urine is a common problem. It is treated with thiazide diuretics. These drugs often cause excessively low blood potassium levels that in turn require large doses of potassium supplements. These supplements are often large, unpleasant and easy to forget. We are trying the addition of spironolactone to these patients' medications to see if it allows them to take a lower dose of potassium. |
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| Detailed Description | See rationale above Ten patients who have had multiple kidney stones primarily due to hypercalciuria and who are currently on stable dose of thiazide or thiazide plus amiloride will be enrolled in the study. In addition, pts have to require at least 60mEq of K supplementation a day or be on 40mEq and be hypokalemic and unable to tolerate increased K supplements. We will then give them 50mg a day of spironolactone for four weeks. A complete 24-hour urine stone profile will be obtained before and after the drug is administered. After four weeks the patients' serum potassium will be rechecked, and their dose will be lowered according to a nomogram. Primary end point is the mean change in serum K before and after spironolactone. Secondary endpoints are the change in urine calcium on and off the drug and the mean reduction in K dose on the drug. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Historical Control, Crossover Assignment, Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Spironolactone | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 10 | ||||||||
| Completion Date | June 2006 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00276289 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 0509-05 | ||||||||
| Study Sponsor ICMJE | Indiana University School of Medicine | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Indiana University | ||||||||
| Verification Date | January 2006 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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