The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism

Not Applicable

Completed

• Conditions: Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

• Registration Number: NCT05649631
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief 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180/110 mmHg), the dose of nifedipine controlled-release tablets will be increased to 60 mg/d. Patients will be withdrawn from the study if they cannot tolerate the diet or their serum potassium were below 2.8 mmol/L.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2022-12
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-07
• Last Update Submitted: 2022-12-07
• Study First Posted: 2022-12-14
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. 18-70 years;
2. diagnosed as PA by SIT;
3. no lateralization of aldosterone secretion during AVS;
4. serum potassium ≥ 2.8 mmol/L after the stage I.

Exclusion Criteria

1. Impaired renal function (Ccr<60 ml/min);
2. Impaired liver function (ALT, AST > 2.5 times upper limit of normal);
3. Patients with heart failure (NYHA≥ class 3 or EF < 50%);
4. Patients with stroke or acute infarction in the last 6 months;
5. Patients who are pregnant or breastfeeding;
6. Patients who cannot tolerate dietary arrangements;
7. Patients with history of malignant tumors in the last 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet	2 weeks

Secondary Outcome Measures

Name	Time	Method
The secondary outcome was the assessment of BP change following a normal sodium / low sodium diet.	2 weeks

Trial Locations

Locations (1)

Yiran Jiang; 🇨🇳 Shanghai, Shanghai, China