The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism

• Sponsor: Shanghai Jiao Tong University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT05649631
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 17
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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180/110 mmHg), the dose of nifedipine controlled-release tablets will be increased to 60 mg/d. Patients will be withdrawn from the study if they cannot tolerate the diet or their serum potassium were below 2.8 mmol/L.

Condition or Disease	Intervention/Treatment	Phase
Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)	Dietary Supplement: Sodium	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism
• Actual Study Start Date: Jul 1, 2021
• Actual Primary Completion Date: Dec 1, 2022
• Actual Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Normal sodium diet(100mmol/d)	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.
Experimental: Low sodium diet(50mmol/d)	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.

Outcome Measures

Primary Outcome Measures

1. The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet [2 weeks]

Secondary Outcome Measures

1. The secondary outcome was the assessment of BP change following a normal sodium / low sodium diet. [2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yiran Jiang	Shanghai	Shanghai	China	200025

Sponsors and Collaborators

• Shanghai Jiao Tong University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wang Weiqing, Director,head of Endocrinololgy,Principal Investigator,Clinical Professor, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT05649631
• Other Study ID Numbers: Ruijin-2020-294
• First Posted: Dec 14, 2022
• Last Update Posted: Dec 14, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Hyperaldosteronism; Hyperplasia

Study Results

No Results Posted as of Dec 14, 2022