Exploratory study into the effect of salt supplementation in Gitelman syndrome

Recruiting

• Conditions: Gitelman syndrome; 10029149

• Registration Number: NL-OMON49231
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Age: * 16 years
- Genetically-proven Gitelman syndrome
- Informed consent

Exclusion Criteria

- inability to discontinue potassium-sparing diuretics, MRAs and NSAIDs; this
means inability to reach a potassium level of 2.5 mmol/L or higher with
maximally tolerable potassium supplementation after discontinuation of
potassium-sparing diuretics.
- patients who are pregnant at time of inclusion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Serum potassium<br /><br>- Personalized symptom scoresheet<br /><br>- Gitelman symptom questionnaire (including the RAND SF-36 QoL score) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Serum electrolytes (sodium, magnesium, chloride, bicarbonate, calcium),<br /><br>aldosterone and renin<br /><br>- Intracellular potassium (measured in erythrocytes)<br /><br>- T helper 17 cell response in peripheral blood mononuclear cells (PBMC)<br /><br>- 24-hour urinary excretion of potassium, sodium, chloride, magnesium, calcium,<br /><br>creatinine, renin and aldosterone<br /><br>- Blood pressure; including determination of orthostatic hypotension<br /><br>- Body weight<br /><br>- Bioimpedance measurement<br /><br>- Muscle strength (measured by hand grip dynamometer)<br /><br>- Potassium and magnesium supplementation requirement</p><br>