Back to resultsThe Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism
Primary Purpose
Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sodium
Sponsored by
About this trial
This is an interventional treatment trial for Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
Eligibility Criteria
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.
Sites / Locations
- Yiran Jiang
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Normal sodium diet(100mmol/d)
Low sodium diet(50mmol/d)
Arm Description
Outcomes
Primary Outcome Measures
The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet
Secondary Outcome Measures
The secondary outcome was the assessment of BP change following a normal sodium / low sodium diet.
Full Information
NCT ID
NCT05649631
First Posted
December 6, 2022
Last Updated
December 7, 2022
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05649631
Brief Title
The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism
Official Title
The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal sodium diet(100mmol/d)
Arm Type
Experimental
Arm Title
Low sodium diet(50mmol/d)
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Sodium
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
The secondary outcome was the assessment of BP change following a normal sodium / low sodium diet.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Yiran Jiang
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism
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