Salt Supplementation in Gitelman Syndrome

NCT04995627 | Completed

• 1 other identifier: NL72495.091.19
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Gitelman Syndrome

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (19)

• Change in serum sodium

  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

  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

  Baseline, week 4, week 8, week 12, week 16, week 20, week 24

Study Arms (2)

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)

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)

Other: Placebo

Interventions

Salt (NaCl) DIETARY_SUPPLEMENT

12 grams of salt (NaCl) per day

Salt (NaCl)

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Genetically-proven, symptomatic Gitelman syndrome
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Dutch Kidney Foundation: collaborator

Study Sites (3)

University Hospital of University of Campania "L. Vanvitelli"

Naples, Italy

Location

Radboudumc

Nijmegen, Gelderland, 6500HB, Netherlands

Location

Erasmus MC

Rotterdam, South Holland, 3000CA, Netherlands

Location

MeSH Terms

Conditions

Gitelman Syndrome

Interventions

Salts

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• Tom Nijenhuis, MD PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single subject multiple randomized double-blinded multi-crossover placebo-controlled trials (N-of-1 trials)

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: August 9, 2021
• Study Start: April 19, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

NL (2); IT (1)