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IRCT20160206026406N3 IRCT 2019-08-13 Shahid Beheshti University of Medical Sciences Comparison of the effect of the calcium citrate supplement with normal calcium diet on metabolic risk factors in recurrent calcium stone formers with hyperoxaluria Comparison of the effect of the calcium citrate supplement with normal calcium diet on metabolic risk factors in recurrent calcium stone formers with hyperoxaluria: a randomized clinical trial 2019-03-21 anticipated 66 Complete https://irct.ir/trial/40112 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with the block size of four will be used, to randomly allocate the patients to loading and maintenance treatment groups and balance patient allocation between groups. Random Allocation software will be used to generate random sequences. Given the random sequences generated, patients will be divided into two groups. 3 Recurrent calcium stone formers with hyperoxaluria. Intervention 1: Intervention group one: Patients receiving daily 800 mg calcium (in two divided doses with lunch and dinner in the form of calcium citrate) plus a diet containing 200 mg of calcium in breakfast meal. Intervention 2: Intervention group two: Patients consume adequate dietary calcium (1000 mg of calcium, divided in meals, 200 mg of breakfast, 400 mg with lunch and 400 mg with dinner). Yes - There is a plan to make this available What will be shared: The information about the type of treatment and the results of 24-hour urine analyses will be available. When: The data could be available one year after the publication of the results. To whom: Data will be available for academic faculty members and researchers. Conditions: The control of the data and supplementary analyses of the data could be performed under copyright law. Where to obtain: Urology and Nephrology Research Center: Dr. Sanaz Tavasoli: s.tavasoli@sbmu.ac.ir Ms. Shabnam Golshan: +98-21-22567222 How to obtain: The applicant must submit a written request to the Urology and Nephrology Research Center. After the approval of the center and the PI of the proposal, the data will be available to the applicant. Comments:
public Sanaz Tavasoli
No 103, 9th Boustan St., Pasdaran Ave.
Tehran Iran (Islamic Republic of) 1666661111 +98 21 2256 7222 sanaz.tavasoli@gmail.com Urology and Nephrology Research Center scientific Sanaz Tavasoli
No 103, 9th Boustan. St., Pasdaran Ave.
Tehran Iran (Islamic Republic of) 1666661111 +98 0212256722 sanaz.tavasoli@gmail.com Urology and Nephrology Research Center Iran (Islamic Republic of) Recurrent stone former Hyperoxaluria (24hr Urine Oxalate between 40-80 mg) Baseline dietary calcium intake less than 800 mg/day The desire to collaborate in the study 18 years 65 years Both Enteric or primary hyperoxaluria (24 hours urine oxalate more than 80 mg) Taking Thiazides or any medicine that has an effect on calcium metabolism Taking any medicine that has an effect on oxalate metabolism Taking vitamin B6 Hepatitis, diabetes, thyroid diseases, hyperparathyroidism, immunological diseases, cancers, chronic diarrhea, chronic kidney diseases and urinary tract infection Pregnancy and lactation N20.0 Calculus of kidney Treatment - Drugs Lifestyle Intervention group one: Patients receiving daily 800 mg calcium (in two divided doses with lunch and dinner in the form of calcium citrate) plus a diet containing 200 mg of calcium in breakfast meal Intervention group two: Patients consume adequate dietary calcium (1000 mg of calcium, divided in meals, 200 mg of breakfast, 400 mg with lunch and 400 mg with dinner) 24hr Urine Oxalate. Timepoint: Before the intervention, 8 weeks after intervention. Method of measurement: Enzymatic method. Calcium oxalate supersaturation. Timepoint: Before the intervention, 8 weeks after intervention. Method of measurement: Calculation by LITHORISK software. Urine pH. Timepoint: Before the intervention, 8 weeks after intervention. Method of measurement: pH meter. 24 hour urine oxalate. Timepoint: Before the intervention, 8 weeks after intervention. Method of measurement: Enzymatic method. Shahid Beheshti University of Medical Sciences Approved 2015-03-14 Ethics committee of Urology and Nephrology research center Urology and Nephrology Research Center, No. 103, Shahid Jafari (9th Boostan) St., Pasdaran Ave. Tehran Tehran Iran (Islamic Republic of)