The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism

Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral) Clinical Trial

Official title:

The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05649631
• Other study ID #: Ruijin-2020-294
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2022
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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180/110 mmHg), the dose of nifedipine controlled-release tablets will be increased to 60 mg/d. Patients will be withdrawn from the study if they cannot tolerate the diet or their serum potassium were below 2.8 mmol/L.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adrenal Hyperplasia, Congenital
• Adrenogenital Syndrome
• Hyperaldosteronism
• Hyperplasia
• Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Intervention

Dietary Supplement:
• Sodium
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.

Locations

Country	Name	City	State
China	Yiran Jiang	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet		2 weeks
Secondary	The secondary outcome was the assessment of BP change following a normal sodium / low sodium diet.		2 weeks