Salt Supplementation in Gitelman Syndrome

Radboud University Medical Center

Status: Completed

Conditions: Gitelman Syndrome

Treatments: Other: Placebo; Dietary Supplement: Salt (NaCl)

Study type: Interventional

Funder types: Other

Identifiers

NCT04995627

NL72495.091.19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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21 participants in 2 patient groups, including a placebo group

Salt (NaCl)

Active Comparator group

Description:

12 grams (12 capsules) of NaCl per day Note: participants will be treated with active and placebo comparator (N-of-1 trial design)

Treatment:

Dietary Supplement: Salt (NaCl)

Placebo

Placebo Comparator group

Description:

12 capsules of placebo per day Note: participants will be treated with active and placebo comparator (N-of-1 trial design)

Treatment:

Other: Placebo