The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism

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180/110 mmHg), the dose of nifedipine controlled-release tablets will be increased to 60 mg/d. Patients will be withdrawn from the study if they cannot tolerate the diet or their serum potassium were below 2.8 mmol/L.

Official Title
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The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism

Conditions
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Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Intervention / Treatment
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* Dietary Supplement: Sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-70 years; diagnosed as PA by SIT; no lateralization of aldosterone secretion during AVS; serum potassium ≥ 2.8 mmol/L after the stage I. Exclusion Criteria: Impaired renal function (Ccr<60 ml/min); Impaired liver function (ALT, AST > 2.5 times upper limit of normal); Patients with heart failure (NYHA≥ class 3 or EF < 50%); Patients with stroke or acute infarction in the last 6 months; Patients who are pregnant or breastfeeding; Patients who cannot tolerate dietary arrangements; Patients with history of malignant tumors in the last 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal sodium diet(100mmol/d)<br> | Dietary Supplement: Sodium<br>* 50 IHA patients were randomized into two groups with low sodium (50mmol/d) and normal sodium (100mmol/d) without potassium supplement. A 14 days dietary intervention was performed respectively to compare the changes in blood pressure (BP) and serum potassium in two groups.<br>|
| Experimental: Low sodium diet(50mmol/d)<br> | Dietary Supplement: Sodium<br>* 50 IHA patients were randomized into two groups with low sodium (50mmol/d) and normal sodium (100mmol/d) without potassium supplement. A 14 days dietary intervention was performed respectively to compare the changes in blood pressure (BP) and serum potassium in two groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcome was the assessment of BP change following a normal sodium / low sodium diet. |  | 2 weeks |