Salt Supplementation in Gitelman Syndrome

November 18, 2024 updated by: Radboud University Medical Center

Exploratory Study Into the Effect of Salt Supplementation in Gitelman Syndrome

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Naples, Italy
        • University Hospital of University of Campania "L. Vanvitelli"
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500HB
        • Radboudumc
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3000CA
        • Erasmus MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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)
Dietary supplement: Salt (NaCl)
12 grams of salt (NaCl) per day
Placebo Comparator: Placebo

12 capsules of placebo per day

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in serum Potassium
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum potassium
Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in symptoms measured by personalized symptom score sheet
Time Frame: Weekly (week 0 till week 24)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in serum sodium
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum sodium
Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum magnesium
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum magnesium
Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum chloride
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum chloride
Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum bicarbonate
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum bicarbonate
Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum calcium
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum calcium
Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum creatinine
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum creatinine
Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum aldosterone
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum aldosterone
Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum renin
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum renin
Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in fractional urinary excretion of potassium
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in fractional urinary excretion of potassium
Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in fractional urinary excretion of sodium
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in fractional urinary excretion of sodium
Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in fractional urinary excretion of chloride
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in fractional urinary excretion of chloride
Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in fractional urinary excretion of magnesium
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in fractional urinary excretion of magnesium
Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in urinary calcium/creatinine ratio
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in urinary calcium/creatinine ratio
Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in urinary excretion of renin
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in urinary excretion of renin
Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in urinary excretion of aldosterone
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in urinary excretion of aldosterone
Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Gitelman symptom questionnaire
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
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
Blood pressure (including orthostatic hypotension measurement)
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Measurement of blood pressure including measurement of orthostatic blood pressure
Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Weight
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Body Weight
Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Muscle strength
Time Frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Muscle strength will be measured by hand grip dynamometer
Baseline, week 4, week 8, week 12, week 16, week 20, week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radboud University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dutch Kidney Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tom Nijenhuis, MD PhD, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL72495.091.19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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