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The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism

NCT ID: NCT05649631

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-12-01

Brief Summary

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180/110 mmHg), the dose of nifedipine controlled-release tablets will be increased to 60 mg/d. Patients will be withdrawn from the study if they cannot tolerate the diet or their serum potassium were below 2.8 mmol/L.

Detailed Description

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Conditions

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Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal sodium diet(100mmol/d)

Group Type EXPERIMENTAL

Sodium

Intervention Type 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)

Group Type EXPERIMENTAL

Sodium

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Wang Weiqing

Director,head of Endocrinololgy,Principal Investigator,Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yiran Jiang

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 37152926 (View on PubMed)

Other Identifiers

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Ruijin-2020-294

Identifier Type: -

Identifier Source: org_study_id