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Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics

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ClinicalTrials.gov Identifier: NCT00276289
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : December 3, 2009
Information provided by:
Indiana University

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.

Condition or disease Intervention/treatment Phase
Idiopathic Hypercalciuria Hypokalemia Caused by Thiazide Diuretics Drug: Spironolactone Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spironolactone to Decrease Potassium Wasting in Hypercalciuric Patients Treated With Thiazide Diuretics
Study Start Date : January 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Primary Outcome Measures :
  1. Change in serum potassium on spironolactone versus off of it

Secondary Outcome Measures :
  1. change in urinary calcium excretion
  2. mean reduction in dose of potassium supplements

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18-65
  • History of idiopathic hypercalciuria (>200mg per 24 hours or a Ca/cr ratio of >140) felt to be the primary etiology of patient's kidney stones
  • History of at least three kidney stone events
  • On same dose of thiazide diuretic for at least three months
  • On stable dose of K 60mEq or more a day to maintain serum K >3.5 or unable to tolerate an increase in K supplement with dose at least 40mEq a day

Exclusion Criteria:

  • Use of ACE inhibitor, ACE receptor blocker or other medication known to effect serum potassium levels
  • GFR <80 by MDRD equation
  • Serious cardiac disease, diabetes, CKD , current or planned pregnancy or breastfeeding
  • History of hypertension

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276289

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United States, Indiana
Indiana University Department of Medicine, Division of Nephrology
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
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Principal Investigator: Sharon S Moe, MD Indiana University
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ClinicalTrials.gov Identifier: NCT00276289    
Other Study ID Numbers: 0509-05
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: December 3, 2009
Last Verified: December 2009
Keywords provided by Indiana University:
thiazide diuretics
Additional relevant MeSH terms:
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Potassium Deficiency
Metabolic Diseases
Nutrition Disorders
Urological Manifestations
Water-Electrolyte Imbalance
Deficiency Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents