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IRCT20160206026406N4 IRCT 2019-08-13 Urology and nephrology research center Evaluation of vitamin D deficiency treatment in patients with calcium kidney stones Comparative study of the effects of hypovitaminosis D treatment with loading and maintenance methods on serum vitamin D status, 24-hour urine calcium, and serum and urine oxidative stress status in patients with calcium kidney stones 2018-07-28 anticipated 60 Complete https://irct.ir/trial/40229 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 Condition 1: Recurrent calcium stone formers. Condition 2: Vitamin D deficiency. Intervention 1: Intervention group 1: This group receives vitamin D with a dose of 50000 IU weekly for 8 weeks. Intervention 2: Intervention group 2: The group receives vitamin D with a dose of 2000 IU daily for 12 weeks. Yes - There is a plan to make this available What will be shared: The original outcome can be shared. 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 Lilit Sardari Masihi
Tehran University of Medical Sciences, Departmant of Nutrition and Dietetic, No 44, Hojatdoost avenue, Naderi street, Keshavarz boulevard
تهران Iran (Islamic Republic of) ۱۴۱۱۷۱۳۱۳۷ +98 21 8895 5975 lilitsardari@gmail.com Tehran University of Medical Sciences scientific 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 Iran (Islamic Republic of) Serum vitamin D 10-20 ng/ml body mass index under 30 Willingness to cooperate in the study 18 years 70 years Both Known Cystine or Struvite kidney stones Hypercalcemia 24-Hour urine calcium higher than 300 mg / 24h Stone pass or gross hematuria in the last 2 months New prescription or changing the dose of thiazide drugs or any drug that has an effect on calcium metabolism Taking antiepileptic or glucocorticoid drugs or any medication that has an effect on vitamin D absorption. Any history of the following diseases: hepatic diseases, diabetes mellitus, thyroid diseases, hyperparathyroidism, immunological diseases, cancers, chronic diarrhea, chronic kidney diseases, urinary tract infection, fat malabsorption, celiac disease, cystic fibrosis. Pregnancy and lactation N20.0 E55 Calculus of kidney Vitamin D deficiency Treatment - Drugs Treatment - Drugs Intervention group 1: This group receives vitamin D with a dose of 50000 IU weekly for 8 weeks. Intervention group 2: The group receives vitamin D with a dose of 2000 IU daily for 12 weeks. 24-hour urine calcium level. Timepoint: Before the intervention and 3 months later. Method of measurement: Colorimetry. Serum vitamin D. Timepoint: Before the intervention and 3 months later. Method of measurement: ELISA. Serum and urine Malondialdehyde. Timepoint: Before the intervention and 3 months later. Method of measurement: Colorimetry. Serum and urine total antioxidant capacity. Timepoint: Before the intervention and 3 months later. Method of measurement: Colorimetry. Serum PTH level. Timepoint: Before the intervention and 3 months later. Method of measurement: ELISA. Serum calcium. Timepoint: Before the intervention and 3 months later. Method of measurement: Colorimetry. 24 hour urine creatinine. Timepoint: Before the intervention and 3 months later. Method of measurement: Colorimetry. 24 hour urine urea. Timepoint: Before the intervention and 3 months later. Method of measurement: Colorimetry. 24 hour urine sodium. Timepoint: Before the intervention and 3 months later. Method of measurement: Ion-selective electrode potentiometry (ISE). Calcium oxalate supersaturation. Timepoint: Before the intervention and 3 months later. Method of measurement: Calculated by LITHORISK software. Calcium phosphate supersaturation. Timepoint: Before the intervention and 3 months later. Method of measurement: Calculated by LITHORISK software. Urology and nephrology research center Approved 2018-06-20 Ethics Committee of Tehran University of Medical Sciences Headquarters of the Ministry of Health- Simaye iran Avenue-shahrak qods (west) tehran tehran Tehran Iran (Islamic Republic of)