Effects of oral sodium thiosulfate in patients with calcium kidney stones

The effects of oral sodium thiosulfate in patients with calcium kidney stones: A randomized, double-blind clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231017059748N2

Enrollment

Registered

2023-10-22

Start date

2023-11-22

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Nephrolithiasis (calcium stones). Calculus of kidney and ureter

Interventions

Intervention 1: Intervention group: Patients will receive 3 grams of oral sodium thiosulfate daily in addition to the usual treatments for 3 months. Intervention 2: Control group: Patients will receiv

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Reducing the size of calcium kidney stones. Timepoint: Baseline, After 1 month, And after 3 months. Method of measurement: Sonography.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHadi Hamishehkar

Tabriz University of Medical Sciences

hamishehkar@gmail.com+98 41 3334 7054

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026