NCT06750172

Simplification of Oral Sodium Loading Test in the Diagnosis of Primary Aldosteronism: 2-day Replacing 3-day Method

Consistency of 24-hour Urinary Aldosterone on on the Second Day and the Third Day in Diagnosis of Primary Aldosteronism Measured in the Oral Sodium Loading Test by Liquid Chromatography-tandem Mass Spectrometry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 33 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

To compare the consistency of 24-hour urinary aldosterone in the diagnosis of primary aldosteronism by oral sodium loading test between the second day method and the third day method

Detailed description

This is an exploratory and prospective study of 17 healthy controls and 15 patients with primary aldosteronism, in which each participant will receive a high-sodium diet for 3 days to conduct a confirmatory test for primary aldosteronism. The consistency between the 2-day and 3-day oral sodium loading test for the diagnosis of primary aldosteronism is compared by measuring the 24-hour urinary aldosterone levels of the participants on the second and third days of the high-sodium diet. The study aims to explore whether the 24-hour urinary aldosterone level on the second day can replace the 24-hour urinary aldosterone level on the third day for the diagnosis of primary aldosteronism.

Conditions

• Primary Aldosteronism

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	The oral sodium loading test	The subjects underwent an oral high-salt diet test with an additional 10g of salt per day for 3 consecutive days, and 24-hour urine measurements of aldosterone, sodium, potassium and creatinine were obtained on days 2 and 3

Timeline

• Start date: 2023-12-15
• Primary completion: 2024-12-25
• Completion: 2024-12-25
• First posted: 2024-12-27
• Last updated: 2024-12-27

Locations

1 site across 1 country: China