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IRCT2017021826406N2 IRCT 2017-06-17 Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences Evaluating the effect of atorvastatin on kidney stone. Evaluating the effect of atorvastatin on metabolic abnormalities, Tubular injury and oxidative stress in recurrent calcium stone patients. 2016-05-21 anticipated 30 Complete https://irct.ir/trial/21899 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Patients will be randomly divided between two groups (using a block randomization design) and will receive three months of drug or placebo accordingly. In order to make the study double blind, one of the project colleagues will code the drugs or placebo and the codes will be kept until the end of the study analyses. The drugs and placebo will be identical and principal investigators who will carry out sampling and testing will be unaware until the end of the study. N/A Calcium kidney stone. Intervention 1: Intervention group: Patients taking atorvastatin oral tab (20 mg). Duration and Dosage: One daily for 3 month. Intervention 2: Control group: Patients taking placebo. Duration and Dosage: One daily for 3 month.
public Sanaz Tavasoli
No 103, 9th Boustan. St., Pasdaran Ave.
Tehran Iran (Islamic Republic of) +98 21 2256 7222 s.tavasoli@sbmu.ac.ir; sanaz.tavasoli@gmail.com Urology and Nephrology Research Center scientific Sanaz Tavasoli
No 103, 9th Boustan. St., Pasdaran Ave.
Tehran Iran (Islamic Republic of) +98 21 2256 7222 s.tavasoli@sbmu.ac.ir; sanaz.tavasoli@gmail.com Urology and Nephrology Research Center Iran (Islamic Republic of) Inclusion criteria: History of calcium kidney stone (stone should be radio-opaque in radiological evaluation); at least 2 times of kidney stone episodes (Recurrent stone); at least 20 days since the last treatment; age 18 to 65 years; Hyperoxaluria (24-hour urine oxalate over 40 and less than 80 mg); willingness to cooperate in the study. Exclusion criteria: Primary or enteric hyperoxaluria (urine oxalate>80 mg/24h);taking any drugs or supplements with antioxidant or anti-inflammatory effects (e.g. steroids, Nonsteroidal Antiinflammatory Drugs, pioglitazone, …), multivitamins containing vitamin A,C or E and any supplement containing anti-oxidants; History of diabetes mellitus, hepatic failure, thyroid or parathyroid diseases, cancers or immunologic diseases, chronic kidney disease (Glomerular filtration rate< 60), Urinary tract infection and chronic diarrhea; Pregnancy or lactation   18 years 65 years Both N20.0 Calculus of kidney Treatment - Drugs Placebo Intervention group: Patients taking atorvastatin oral tab (20 mg). Duration and Dosage: One daily for 3 month. Control group: Patients taking placebo. Duration and Dosage: One daily for 3 month Urine malondialdehyde. Timepoint: Before the intervention, 3 months after the intervention. Method of measurement: colorimetric method using Thiobarbituric acid. Urine neutrophil gelatinase-associated lipocalin. Timepoint: Before the intervention, 3 months after the intervention. Method of measurement: ELISA. Morning urine pH. Timepoint: Before the intervention,3 months after the intervention. Method of measurement: Dip stick. 24 hour urine volume. Timepoint: Before the intervention,3 months after the intervention. Method of measurement: observation. 24 hour urine creatinine. Timepoint: Before the intervention,3 months after the intervention. Method of measurement: Colorimetric. 24 hour urine calcium. Timepoint: Before the intervention,3 months after the intervention. Method of measurement: Colorimetric. 24 hour urine oxalate. Timepoint: Before the intervention,3 months after the intervention. Method of measurement: Assay kit with Enzymatic method. 24 hour urine phosphorus. Timepoint: Before the intervention,3 months after the intervention. Method of measurement: Colorimetric. 24 hour urine magnesium. Timepoint: Before the intervention,3 months after the intervention. Method of measurement: Colorimetric. 24 hour urine citrate. Timepoint: Before the intervention,3 months after the intervention. Method of measurement: Assay kit with Enzymatic method. 24 hour urine uric acid. Timepoint: Before the intervention,3 months after the intervention. Method of measurement: Colorimetric. 24 hour urine sodium. Timepoint: Before the intervention,3 months after the intervention. Method of measurement: flame photometry or indirect ion selective electrode. 24 hour urine potassium. Timepoint: Before the intervention,3 months after the intervention. Method of measurement: flame photometry or indirect ion selective electrode. 24 hour urine chloride. Timepoint: Before the intervention,3 months after the intervention. Method of measurement: flame photometry or indirect ion selective electrode. Calcium oxalate relative supersaturation. Timepoint: Before the intervention,3 months after the intervention. Method of measurement: calculation by lithorisk software. Calcium phosphate relative supersaturation. Timepoint: Before the intervention,3 months after the intervention. Method of measurement: calculation by lithorisk software. Uric acid relative supersaturation. Timepoint: Before the intervention,3 months after the intervention. Method of measurement: calculation by lithorisk software. Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences Approved 2015-03-14 Ethics committee of Urology and Nephrology research center, Shahid Beheshti University of Medical Sc N0. 103 - 9th Boostan St., Pasdaran St. Tehran Iran (Islamic Republic of)