Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00004328 |
| Other study ID # |
199/11883 |
| Secondary ID |
UTMB-403 |
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
October 18, 1999 |
| Last updated |
June 23, 2005 |
| Start date |
December 1992 |
Study information
| Verified date |
May 2000 |
| Source |
Office of Rare Diseases (ORD) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Interventional
|
Clinical Trial Summary
OBJECTIVES: I. Establish the sodium and potassium intake that will maintain a normovolemic
state in a patient with pseudohypoaldosteronism.
II. Determine the effect of extracellular fluid volume and serum potassium manipulations on
exercise tolerance, cardiac function, and endurance.
III. Investigate pharmacologic methods of limiting excretion of sodium in urine and sweat.
Description:
PROTOCOL OUTLINE: Sodium and potassium intake resulting in normalization of serum
electrolytes and markers of extracellular volume are determined at baseline. A trial diet is
then prescribed, with adjustments made to achieve a steady state with normal serum
electrolytes. Exercise tolerance and muscle function are evaluated at steady state.
Sodium and potassium are sequentially manipulated with diet, enalapril, and polystyrene
sulfonate. Exercise tolerance is evaluated during each diet period.
A treatment plan to maintain electrolyte balance is developed. The patient is followed
monthly for 3 to 6 months, then every 3 months for up to 3 years.
