Salt Supplementation in Gitelman Syndrome

Last updated: November 18, 2024
Sponsor: Radboud University Medical Center
Overall Status: Completed

Phase

N/A

Condition

Kidney Failure (Pediatric)

Kidney Disease

Kidney Failure

Treatment

Salt (NaCl)

Placebo

Clinical Study ID

NCT04995627
NL72495.091.19
  • Ages > 16
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Genetically-proven, symptomatic Gitelman syndrome

  • Written informed consent

Exclusion

Exclusion Criteria:

  • inability to discontinue potassium-sparing diuretics, mineralocorticoid antagonistsand NSAIDs; this means inability to reach a potassium level of 2.5 mmol/L or higherwith maximally tolerable potassium supplementation after discontinuation ofpotassium-sparing diuretics

  • pregnancy

Study Design

Total Participants: 21
Treatment Group(s): 2
Primary Treatment: Salt (NaCl)
Phase:
Study Start date:
April 19, 2021
Estimated Completion Date:
September 01, 2024

Study 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.

Connect with a study center

  • University Hospital of University of Campania "L. Vanvitelli"

    Naples,
    Italy

    Site Not Available

  • Radboudumc

    Nijmegen, Gelderland 6500HB
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam, Zuid-Holland 3000CA
    Netherlands

    Site Not Available

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