The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism

NCT05649631 | Completed

• 1 other identifier: Ruijin-2020-294
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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180/110 mmHg), the dose of nifedipine controlled-release tablets will be increased to 60 mg/d. Patients will be withdrawn from the study if they cannot tolerate the diet or their serum potassium were below 2.8 mmol/L.

Conditions

Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Outcome Measures

Primary Outcomes (1)

• The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet

  2 weeks

Secondary Outcomes (1)

• The secondary outcome was the assessment of BP change following a normal sodium / low sodium diet.

  2 weeks

Study Arms (2)

Normal sodium diet(100mmol/d)

EXPERIMENTAL

Dietary Supplement: Sodium

Low sodium diet(50mmol/d)

EXPERIMENTAL

Dietary Supplement: Sodium

Interventions

Sodium DIETARY_SUPPLEMENT

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.

Low sodium diet(50mmol/d); Normal sodium diet(100mmol/d)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years;
• diagnosed as PA by SIT;
• no lateralization of aldosterone secretion during AVS;
• serum potassium ≥ 2.8 mmol/L after the stage I.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Yiran Jiang

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

• Zhou L, Jiang Y, Zhang C, Su T, Jiang L, Zhou W, Zhong X, Wu L, Wang W. Effects of a low-sodium diet in patients with idiopathic hyperaldosteronism: a randomized controlled trial. Front Endocrinol (Lausanne). 2023 Apr 19;14:1124479. doi: 10.3389/fendo.2023.1124479. eCollection 2023.

  PMID: 37152926 DERIVED

MeSH Terms

Interventions

Sodium

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director,head of Endocrinololgy,Principal Investigator,Clinical Professor

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: July 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)