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| Name | Class |
|---|---|
| Dutch Kidney Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Placebo | Placebo Comparator | 12 capsules of placebo per day Note: participants will be treated with active and placebo comparator (N-of-1 trial design) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salt (NaCl) | Dietary Supplement | 12 grams of salt (NaCl) per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum Potassium | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum sodium | Change in serum sodium | Baseline, week 4, week 8, week 12, week 16, week 20, week 24 |
| Change in serum magnesium | Change in serum magnesium |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tom Nijenhuis, MD PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of University of Campania "L. Vanvitelli" | Naples | Italy | ||||
| Radboudumc |
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| ID | Term |
|---|---|
| D053579 | Gitelman Syndrome |
| ID | Term |
|---|---|
| D015499 | Renal Tubular Transport, Inborn Errors |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D012492 | Salts |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
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Single subject multiple randomized double-blinded multi-crossover placebo-controlled trials (N-of-1 trials)
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| Placebo |
| Other |
Placebo |
|
| Baseline, week 4, week 8, week 12, week 16, week 20, week 24 |
| Change in serum chloride | Change in serum chloride | Baseline, week 4, week 8, week 12, week 16, week 20, week 24 |
| Change in serum bicarbonate | Change in serum bicarbonate | Baseline, week 4, week 8, week 12, week 16, week 20, week 24 |
| Change in serum calcium | Change in serum calcium | Baseline, week 4, week 8, week 12, week 16, week 20, week 24 |
| Change in serum creatinine | Change in serum creatinine | Baseline, week 4, week 8, week 12, week 16, week 20, week 24 |
| Change in serum aldosterone | Change in serum aldosterone | Baseline, week 4, week 8, week 12, week 16, week 20, week 24 |
| Change in serum renin | Change in serum renin | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Baseline, week 4, week 8, week 12, week 16, week 20, week 24 |
| Weight | Body Weight | Baseline, week 4, week 8, week 12, week 16, week 20, week 24 |
| Muscle strength | Muscle strength will be measured by hand grip dynamometer | Baseline, week 4, week 8, week 12, week 16, week 20, week 24 |
| Nijmegen |
| Gelderland |
| 6500HB |
| Netherlands |
| Erasmus MC | Rotterdam | South Holland | 3000CA | Netherlands |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |