Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics
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.
Hypokalemia Caused by Thiazide Diuretics
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Spironolactone to Decrease Potassium Wasting in Hypercalciuric Patients Treated With Thiazide Diuretics|
- Change in serum potassium on spironolactone versus off of it
- change in urinary calcium excretion
- mean reduction in dose of potassium supplements
|Study Start Date:||January 2006|
|Study Completion Date:||June 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276289
|United States, Indiana|
|Indiana University Department of Medicine, Division of Nephrology|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Sharon S Moe, MD||Indiana University|