Clinical Trial: Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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.
Detailed Summary:
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.
Sponsor: Indiana University School of Medicine
Current Primary Outcome: Change in serum potassium on spironolactone versus off of it
Original Primary Outcome: Same as current
Current Secondary Outcome:
- change in urinary calcium excretion
- mean reduction in dose of potassium supplements
Original Secondary Outcome: Same as current
Information By: Indiana University
Dates:
Date Received: January 11, 2006
Date Started: January 2006
Date Completion:
Last Updated: December 2, 2009
Last Verified: December 2009
