Exploratory study into the effect of salt supplementation in Gitelman syndrome

Exploratory study into the effect of salt supplementation in Gitelman syndrome - Salt supplementation in Gitelman syndrome

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49231

Enrollment

Registered

2020-09-08

Start date

2021-04-19

Completion date

Unknown

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gitelman syndrome

Interventions

Salt supplementation: 12 grams of NaCl per day. This will be administered in a double-blinded randomized order alternating with placebo capsules, each treatment block lasting for 4 weeks.

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age: >= 16 years - Genetically-proven Gitelman syndrome - Informed consent

Exclusion criteria

Exclusion criteria: - inability to discontinue potassium-sparing diuretics, MRAs 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. - patients who are pregnant at time of inclusion

Design outcomes

Primary

Measure	Time frame
- Serum potassium - Personalized symptom scoresheet - Gitelman symptom questionnaire (including the RAND SF-36 QoL score)	—

Secondary

Measure	Time frame
- Serum electrolytes (sodium, magnesium, chloride, bicarbonate, calcium), aldosterone and renin - Intracellular potassium (measured in erythrocytes) - T helper 17 cell response in peripheral blood mononuclear cells (PBMC) - 24-hour urinary excretion of potassium, sodium, chloride, magnesium, calcium, creatinine, renin and aldosterone - Blood pressure; including determination of orthostatic hypotension - Body weight - Bioimpedance measurement - Muscle strength (measured by hand grip dynamometer) - Potassium and magnesium supplementation requirement	—

Measure

Time frame

- Serum electrolytes (sodium, magnesium, chloride, bicarbonate, calcium), aldosterone and renin - Intracellular potassium (measured in erythrocytes) - T helper 17 cell response in peripheral blood mononuclear cells (PBMC) - 24-hour urinary excretion of potassium, sodium, chloride, magnesium, calcium, creatinine, renin and aldosterone - Blood pressure; including determination of orthostatic hypotension - Body weight - Bioimpedance measurement - Muscle strength (measured by hand grip dynamometer) - Potassium and magnesium supplementation requirement

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)