Effects of oral sodium thiosulfate in patients with calcium kidney stones
Phase 3
- Conditions
- ephrolithiasis (calcium stones).Calculus of kidney and ureter
- Registration Number
- IRCT20231017059748N2
- Lead Sponsor
- Tabriz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Patients over 18 years old with kidney stones who are candidates for standard treatment.
Recurrent kidney stone disease
Any previous kidney stones containing 50% or more calcium oxalate, calcium phosphate, or a mixture of both.
Exclusion Criteria
Active malignancy
Patients using SGLT2i drugs, topiramate, carbonic anhydrase inhibitors, loop diuretics, glucocorticoids, laxatives
Electrolyte disorders: hypokalemia (blood potassium level less than 3 mmol/L) or hypernatremia (blood sodium level >145 mmol/L) in initial tests
Urinary tract infection if not treated successfully
Pregnant and lactating women
Participation in another clinical trials
Inability to understand and follow protocol
Known allergy to the study medicine
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reducing the size of calcium kidney stones. Timepoint: Baseline, After 1 month, And after 3 months. Method of measurement: Sonography.
- Secondary Outcome Measures
Name Time Method The rate of improvement in complications and clinical symptoms of kidney stones. Timepoint: Baseline, After 1 month, And after 3 month. Method of measurement: Questionnaire.;Changes in serum levels of electrolytes, BUN, creatinine, liver enzymes, CBC and urinalysis. Timepoint: Baseline, After 1 month, And after 3 month. Method of measurement: Blood and urine samples.;The incidence and severity of possible side effects caused by sodium thiosulfate. Timepoint: Baseline, After 1 month, And after 3 month. Method of measurement: Questionnaire.