NCT04995627

Salt Supplementation in Gitelman Syndrome

Exploratory Study Into the Effect of Salt Supplementation in Gitelman Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Gitelman Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Salt (NaCl)	12 grams of salt (NaCl) per day
OTHER	Placebo	Placebo

Timeline

• Start date: 2021-04-19
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2021-08-09
• Last updated: 2024-11-21

Locations

3 sites across 2 countries: Italy, Netherlands