Salt Supplementation in Gitelman Syndrome

Gitelman Syndrome Clinical Trial

Official title:

Exploratory Study Into the Effect of Salt Supplementation in Gitelman Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04995627
• Other study ID #: NL72495.091.19
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: November 2023
• Source: Radboud University Medical Center
• Contact: Maartje FA Verploegen, MD
• Phone: +31243614761
• Email: Maartje.Verploegen[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of salt (NaCl) supplementation on serum potassium and clinical signs and symptoms in patients with Gitelman syndrome.

Description:

Single subject multiple randomized double-blinded multi-crossover placebo-controlled trials (N-of-1 trials) will be performed. Participants will enroll the study after giving written informed consent. The individual trials will consist of 3 treatment blocks which each contain a 4-week treatment period of salt supplementation (12 grams of NaCl) and a 4-week treatment period of placebo, in a randomized, blinded order. After each period of 4 weeks, outcomes measures will be measured.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Genetically-proven, symptomatic Gitelman syndrome

• Written informed consent

Exclusion Criteria:

• inability to discontinue potassium-sparing diuretics, mineralocorticoid antagonists 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

• pregnancy

Related Conditions & MeSH terms

• Gitelman Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Salt (NaCl)
12 grams of salt (NaCl) per day

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Italy	University Hospital of University of Campania "L. Vanvitelli"	Naples
Netherlands	Radboudumc	Nijmegen	Gelderland
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Dutch Kidney Foundation

Countries where clinical trial is conducted

Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum Potassium	Change in serum potassium	Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Primary	Change in symptoms measured by personalized symptom score sheet	Symptoms will be scored via a personalized symptom score sheet, which will be composed with the individual participant. Symptoms will be scored at a range from 0 - 10	Weekly (week 0 till week 24)
Secondary	Change in serum sodium	Change in serum sodium	Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Secondary	Change in serum magnesium	Change in serum magnesium	Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Secondary	Change in serum chloride	Change in serum chloride	Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Secondary	Change in serum bicarbonate	Change in serum bicarbonate	Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Secondary	Change in serum calcium	Change in serum calcium	Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Secondary	Change in serum creatinine	Change in serum creatinine	Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Secondary	Change in serum aldosterone	Change in serum aldosterone	Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Secondary	Change in serum renin	Change in serum renin	Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Secondary	Change in fractional urinary excretion of potassium	Change in fractional urinary excretion of potassium	Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Secondary	Change in fractional urinary excretion of sodium	Change in fractional urinary excretion of sodium	Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Secondary	Change in fractional urinary excretion of chloride	Change in fractional urinary excretion of chloride	Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Secondary	Change in fractional urinary excretion of magnesium	Change in fractional urinary excretion of magnesium	Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Secondary	Change in urinary calcium/creatinine ratio	Change in urinary calcium/creatinine ratio	Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Secondary	Change in urinary excretion of renin	Change in urinary excretion of renin	Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Secondary	Change in urinary excretion of aldosterone	Change in urinary excretion of aldosterone	Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Secondary	Gitelman symptom questionnaire	With the Gitelman symptom questionnaire, symptoms can be scored for frequency of apperance and severity. This questionnaire also contains the 36-Item Short Form Health Survey (RAND SF-36) quality of life questionnaire	Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Secondary	Blood pressure (including orthostatic hypotension measurement)	Measurement of blood pressure including measurement of orthostatic blood pressure	Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Secondary	Weight	Body Weight	Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Secondary	Muscle strength	Muscle strength will be measured by hand grip dynamometer	Baseline, week 4, week 8, week 12, week 16, week 20, week 24