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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
21
12 grams of salt (NaCl) per day
Placebo
University Hospital of University of Campania "L. Vanvitelli"
Naples, Italy
Radboudumc
Nijmegen, Gelderland, Netherlands
Erasmus MC
Rotterdam, South Holland, Netherlands
Change in serum Potassium
Change in serum potassium
Time frame: 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
Time frame: Weekly (week 0 till week 24)
Change in serum sodium
Change in serum sodium
Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum magnesium
Change in serum magnesium
Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum chloride
Change in serum chloride
Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum bicarbonate
Change in serum bicarbonate
Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum calcium
Change in serum calcium
Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum creatinine
Change in serum creatinine
Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
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Change in serum aldosterone
Change in serum aldosterone
Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Change in serum renin
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
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
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
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
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
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
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
Change in urinary excretion of aldosterone
Time frame: 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
Time frame: 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
Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Weight
Body Weight
Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Muscle strength
Muscle strength will be measured by hand grip dynamometer
Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24