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IRCT20191026045244N1 IRCT 2019-12-03 Shahid Beheshti University of Medical Sciences The effect of magnesium supplementation on hyperoxaluria and calcium oxalate supersaturation in kidney stone patients The effect of oral magnesium citrate and magnesium oxide supplementation on hyperoxaluria and calcium oxalate supersaturation in kidney stone patients 2016-06-21 anticipated 99 Complete https://irct.ir/trial/43283 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with the block size of four was used, to randomly allocate the patients to Magnesium oxide, Magnesium citrate and Placebo groups and balance patient allocation between groups. Random Allocation software was used to generate random sequences. Given the random sequences generated, patients were divided into three groups, Blinding description: The form of the drug in the three groups of magnesium oxide, magnesium citrate and placebo was quite similar and participants would not be informed about participation in which of the three study groups. 3 kidney stone. Intervention 1: Intervention group: Magnesium Oxide. Intervention 2: Intervention group: Magnesium Citrate. Intervention 3: Control group: Placebo. 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. Maryam Taheri: taheri233@yahoo.com/ 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 Maryam Taheri
No 103, 9th Boustan St., Pasdaran Ave.
Tehran Iran (Islamic Republic of) 11666668111 +98 0212256722 taheri233@yahoo.com Shahid Beheshti University of Medical Sciences scientific Maryam Taheri
No 103, 9th Boustan. St., Pasdaran Ave.
Tehran Iran (Islamic Republic of) 11666668111 +98 0212256722 taheri233@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Hyperoxaluria (24-hour urine oxalate over 40 and less than 80 mg) Patients with a history of kidney stone referred to kidney stone prevention clinic of Labbafinejad at least 20 days since the last treatment they have at least 3 months since following general dietary advice on recurrence prevention (drinking advice, high oxalate food restriction, animal protein restriction, fruit and vegetable intake encouragement, salt restriction and fat intake modification) willingness to cooperate in the study 18 years 65 years Both Primary or enteric hyperoxaluria (urine oxalate>80 mg/24h) Taking any drugs which affects calcium metabolism, including thiazides, potassium citrate, calcium supplement, magnesium supplement and Laxatives Taking any drugs which affects oxalate metabolism or calcium oxalate supersaturation, including vitamin B6 History of diabetes mellitus, hepatic failure, thyroid or parathyroid diseases, chronic kiodney disease (CKD), Urinary tract infection (UTI), chronic diarrhea or immunologic diseases Pregnancy or lactation N20.0 Calculus of kidney Treatment - Drugs Treatment - Drugs Placebo Intervention group: Magnesium Oxide Intervention group: Magnesium Citrate Control group: Placebo 24 hour 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. 24 hour urine magnesium. Timepoint: Before the intervention, 8 weeks after intervention. Method of measurement: Chemical Method - Calorimetry. 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)