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Completed

NCT Number: NCT04995627

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.

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Key information

Conditions

Gitelman Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Male Urogenital Diseases Renal Tubular Transport, Inborn Errors Urogenital Diseases Urologic Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of University of Campania "L. Vanvitelli", Naples, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salt (NaCl)

Dietary Supplement

12 grams of salt (NaCl) per day

Placebo

Other

Placebo

Primary outcomes

  1. Change in serum Potassium

    Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24

    Change in serum potassium

  2. 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

Secondary outcomes

  1. Change in serum sodium

    Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24

    Change in serum sodium

  2. Change in serum magnesium

    Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24

    Change in serum magnesium

  3. Change in serum chloride

    Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24

    Change in serum chloride

  4. Change in serum bicarbonate

    Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24

    Change in serum bicarbonate

  5. Change in serum calcium

    Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24

    Change in serum calcium

  6. Change in serum creatinine

    Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24

    Change in serum creatinine

  7. Change in serum aldosterone

    Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24

    Change in serum aldosterone

  8. Change in serum renin

    Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24

    Change in serum renin

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. Weight

    Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24

    Body Weight

  19. 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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Dutch Kidney Foundation

Registry information

Official study title

Exploratory Study Into the Effect of Salt Supplementation in Gitelman Syndrome

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2021
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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