Salt Supplementation in Gitelman Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-19

Study Completion Date

2024-09-01

Brief Summary

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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.

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Detailed Description

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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

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Gitelman Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Single subject multiple randomized double-blinded multi-crossover placebo-controlled trials (N-of-1 trials)

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Salt (NaCl)

12 grams (12 capsules) of NaCl per day

Note: participants will be treated with active and placebo comparator (N-of-1 trial design)

Group Type ACTIVE_COMPARATOR

Salt (NaCl)

Intervention Type DIETARY_SUPPLEMENT

12 grams of salt (NaCl) per day

Placebo

12 capsules of placebo per day

Note: participants will be treated with active and placebo comparator (N-of-1 trial design)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Salt (NaCl)

12 grams of salt (NaCl) per day

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No