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IRCT20231017059748N2 IRCT 2023-10-22 Tabriz University of Medical Sciences 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 2023-11-22 anticipated 70 Complete https://irct.ir/trial/73264 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be carried out using the random allocation site (https://www.sealedenvelope.com/simple-randomiser/v1/lists) by blocked randomization method with random block size 4 and 6, Blinding description: This study is double-blind and none of the patients and researchers will know about the process of assigning patients to the intervention and placebo groups. For this purpose, sodium thiosulfate and placebo will be similarly packaged and given to the patient. Also, sodium thiosulfate and placebo tablets will have the same shape, color, and size. 3 Nephrolithiasis (calcium stones). 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 receive a placebo daily for 3 month along with usual treatments. Yes - There is a plan to make this available What will be shared: All of the data of an article can be published after making patients unrecognized. When: After publishing of article until 6 months after publishing of the results To whom: Data will be available to researchers working in academic and scientific institutions. Conditions: Researchers who request data will be permitted only to do analysis according to ethics for scientific aims. Where to obtain: Applicants can receive data by sending an E-mail to address of hamishehkar@gmail.com and get response from Dr. Hadi Hamishehkar. How to obtain: After contacting the corresponding author(Dr. Hadi Hamishehkar), data will be sent to the Tabriz Imam Reza hospital ethics committee and after receiving permission, data will be sent to applicants. Comments:
public Hadi Hamishehkar
Imam Reza Educational and Medical Center, in front of the central organization of the University, Golgasht St., Tabriz
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 7054 hamishehkar@gmail.com Tabriz University of Medical Sciences scientific Hadi Hamishehkar
Imam Reza Educational and Medical Center, in front of the central organization of the University, Golgasht St., Tabriz
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 7054 hamishehkar@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 80 years Both 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 N20 Calculus of kidney and ureter Treatment - Drugs Treatment - Drugs Intervention group: Patients will receive 3 grams of oral sodium thiosulfate daily in addition to the usual treatments for 3 months. Control group: Patients will receive a placebo daily for 3 month along with usual treatments. Reducing the size of calcium kidney stones. Timepoint: Baseline, After 1 month, And after 3 months. Method of measurement: Sonography. 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. Tabriz University of Medical Sciences Approved 2023-08-07 Ethics committee of Tabriz University of Medical Sciences Research & Technology Dept, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golghast St, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)