The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism
The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism
NCT ID: NCT05649631 Phase: NA Status: COMPLETED Enrollment: 50 Completion: 2022-12-01
Conditions
Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
Interventions
Sodium
Summary
This study was a single-center randomized controlled trial which lasted 14 days and consisted of two stages (run-in period (stage I) and intervention period (stage II) each contain 7 days without potassium supplement. If participants meet the enrollment criteria at the end of stage I, they were assigned to the low sodium group (50mmol/d) or normal sodium group (100mmol/d), and then continued to finish stage II. The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet and the secondary outcome was the assessment of BP change following a normal sodium / low sodium diet. Patients were given nifedipine controlled-release tablets 30 mg/d to lower blood pressure and were not provided any potassium supplements during the two stages. If the subject has an increase in BP (>180/110 mmHg), the dose of nifedipine controlled-release tablets will be increased to 60 mg/d. Patients will be withdrawn from the study if they cannot tolerate the diet or their serum potassium were below 2.8 mmol/L.
Primary Outcome
The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet