Gitelman SyndromeNCT04995627
Salt Supplementation in Gitelman Syndrome
A study testing Salt (NaCl) in people with Gitelman Syndrome, run by Radboud University Medical Center at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Gitelman Syndrome
- What is being tested?
- Salt (NaCl)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 19 Apr 2021to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Genetically-proven, symptomatic Gitelman syndrome
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Netherlands2 sites
Radboudumc
Nijmegen, Gelderland, 6500HB
Erasmus MC
Rotterdam, South Holland, 3000CA
Italy1 site
University Hospital of University of Campania "L. Vanvitelli"
Naples
About this study
Official title: 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.
Read the 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
- Being tested
- Salt (NaCl), Placebo
- Medical subject headings
- Gitelman Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salt (NaCl)Dietary supplement
12 grams of salt (NaCl) per day
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Salt (NaCl) | Active comparator | 12 grams (12 capsules) of NaCl per day
Note: participants will be treated with active and placebo comparator (N-of-1 trial design) Receives: Dietary Supplement: Salt (NaCl) |
| Placebo | Placebo comparator | 12 capsules of placebo per day
Note: participants will be treated with active and placebo comparator (N-of-1 trial design) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum Potassium
Change in serum potassium
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
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
Measured: Weekly (week 0 till week 24)
Secondary outcomes (19)
Change in serum sodium
Change in serum sodium
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum magnesium
Change in serum magnesium
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum chloride
Change in serum chloride
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum bicarbonate
Change in serum bicarbonate
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum calcium
Change in serum calcium
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum creatinine
Change in serum creatinine
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum aldosterone
Change in serum aldosterone
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum renin
Change in serum renin
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in fractional urinary excretion of potassium
Change in fractional urinary excretion of potassium
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in fractional urinary excretion of sodium
Change in fractional urinary excretion of sodium
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in fractional urinary excretion of chloride
Change in fractional urinary excretion of chloride
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in fractional urinary excretion of magnesium
Change in fractional urinary excretion of magnesium
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in urinary calcium/creatinine ratio
Change in urinary calcium/creatinine ratio
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in urinary excretion of renin
Change in urinary excretion of renin
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in urinary excretion of aldosterone
Change in urinary excretion of aldosterone
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
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
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Blood pressure (including orthostatic hypotension measurement)
Measurement of blood pressure including measurement of orthostatic blood pressure
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Weight
Body Weight
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Muscle strength
Muscle strength will be measured by hand grip dynamometer
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start19 Apr 2021
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gitelman SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single subject multiple randomized double-blinded multi-crossover placebo-controlled trials (N-of-1 trials)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Kidney Foundation
- Responsible party
- Sponsor
- Investigators
- Tom Nijenhuis, MD PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995627
- Sponsor's protocol ID
- NL72495.091.19
- Status last verified
- Nov 2024
- First submitted
- 18 Jul 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study Into the Effect of Salt Supplementation in Gitelman Syndrome
- ClinicalTrials.gov ID
- NCT04995627
- Acronym / sponsor ID
- NL72495.091.19
- Conditions
- Gitelman Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Kidney Foundation
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single subject multiple randomized double-blinded multi-crossover placebo-controlled trials (N-of-1 trials)
| Arm | Type | Receives |
|---|---|---|
| Salt (NaCl) | Active comparator | Dietary Supplement: 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) |
| Placebo | Placebo comparator | Other: Placebo12 capsules of placebo per day Note: participants will be treated with active and placebo comparator (N-of-1 trial design) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Genetically-proven, symptomatic Gitelman syndrome
- Written informed consent
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salt (NaCl)12 grams of salt (NaCl) per day | Dietary supplement | Salt (NaCl) |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Change in serum Potassium
Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum potassium
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
19 secondary outcomes
Change in serum sodium
Time frame: 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 chloride
Time frame: 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 calcium
Time frame: 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 aldosterone
Time frame: 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 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 sodium
Time frame: 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 magnesium
Time frame: 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 excretion of renin
Time frame: 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
Gitelman symptom questionnaire
Time frame: 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
Weight
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Gitelman Syndrome
RecruitingObservational study
The Osteoarticular Manifestations in Patients With Gitelman Syndrome
Gitelman Syndrome, CPPD - Calcium Pyrophosphate Deposition Disease
RecruitingObservational study
National Registry of Rare Kidney Diseases
Adenine Phosphoribosyltransferase Deficiency, AH Amyloidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Nijenhuis, MD PhD principal investigator
Radboud University Medical Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salt (NaCl) in people with Gitelman Syndrome, run by Radboud University Medical Center at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum Potassium (time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.