The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism

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180/110 mmHg), the dose of nifedipine controlled-release tablets will be increased to 60 mg/d. Patients will be withdrawn from the study if they cannot tolerate the diet or their serum potassium were below 2.8 mmol/L.

Study Overview

• Status: Completed
• Conditions: Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
• Intervention / Treatment: Dietary supplement: Sodium

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Yiran Jiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Estimate): December 14, 2022

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Endocrine System Diseases; Gonadal Disorders; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Steroid Metabolism, Inborn Errors; Hyperplasia; Hyperaldosteronism; Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome
• Other Study ID Numbers: Ruijin-2020-294

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No