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Completed

NCT Number: NCT05649631

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180/110 mmHg), the dose of nifedipine controlled-release tablets will be increased to 60 mg/d. Patients will be withdrawn from the study if they cannot tolerate the diet or their serum potassium were below 2.8 mmol/L.

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Key information

Conditions

Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yiran Jiang

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 2 weeks

Secondary outcomes

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

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 14, 2022
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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