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IRCT20090609002017N34 IRCT 2019-04-07 Tabriz University of Medical Sciences The effects of sodium pentaborate (NaB) supplementation on calculi status and related metabolic risk factors in patient with kidney stone The effects of sodium pentaborate (NaB) supplementation on calculi status and related metabolic risk factors in patient with kidney stone 2019-06-21 anticipated 120 Complete https://irct.ir/trial/38398 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: From among the patients who volunteer to participate in the study, 120 individuals will be selected by simple randomization. Then by using the Random Allocation Software, the subjects will be allocated into either pentaborate or placebo group, stratified BMI, Blinding description: In this study, the main investigators as well as the patients will be blinded to the type of the supplement (pentaborate or placebo) received by each group. The person responsible for preparing the supplement capsules (who is completely unrelated to the study) will be asked to assign a three digit code to each of the two capsules (sodium pentaborate and placebo), and keep the codes for himself until the end of the study and data analyses. N/A kidney stone. Intervention 1: intervention group: n= 80. Patients in this group will receive 2 capsules of sodium pentaborate (NaB) supplements for 8 weeks daily . each capsules contain 5 mg sodium pentaborate (NaB). Intervention 2: Control group: n= 30. Patients in this group will receive 2 capsules of pelacebo (Carboxymethyl cellulose) for 8 weeks daily . each capsules contain 5 mg Carboxymethyl cellulose. and 10 patients as a negative control will not receive any capsules. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared. When: access starting 12 months after publication To whom: The data will only be available for people working in academic institution. Conditions: The data of the present study will only be accessible by other researchers, for conducting Meta-analysis Where to obtain: To access the required data, the researchers can contact Dr.alireza ostadrahimi. E-mail address: ostadrahimi@tbzmed.ac.ir How to obtain: The applicant should provide a brief description of the aims and methods of his Meta-analysis. His request will be assessed by the researchers, and if all of them agree to the request, the requested data will be emailed to the applicant in an Excel file format. All these procedures will take no longer than 20 days. Comments:
public Maryam Behrooz
Faculty of Nutrition and Food Sciences, Attar Neyshabouri Av., Golgasht St.
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 2292 mm.behroozp@gmail.com Tabriz University of Medical Sciences scientific Dr. Alireza Ostadrahimi
Nutrition Faculty, Attar Neyshaburi Ave, Golgasht St, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 2292 ostadrahimi@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Men and women aged 20-50 years Patients with kidney stones with urologist diagnosis (other than obstructive, infectious, and ureter stones) Patients with kidney stones who, can be follow with drug therapy for a maximum of 3 month,according to a urologist diagnosis Not suffering from liver and kidney failure Patients who are willing to participate in the study 20 years 50 years Both Pregnancy or lactation Suffering from other kidney related metabolic disorders and disease, at the same time Smoking Having a special diet Patients with obstructive stones, infections, and ureter stones and Emergency cases requiring special treatment or surgery with the diagnosis of urologists Changes in the drug protocol during the study N20 Calculus of kidney and ureter Treatment - Drugs Placebo intervention group: n= 80. Patients in this group will receive 2 capsules of sodium pentaborate (NaB) supplements for 8 weeks daily . each capsules contain 5 mg sodium pentaborate (NaB) Control group: n= 30. Patients in this group will receive 2 capsules of pelacebo (Carboxymethyl cellulose) for 8 weeks daily . each capsules contain 5 mg Carboxymethyl cellulose. and 10 patients as a negative control will not receive any capsules. Calculi status. Timepoint: Weeks 0, 4 and 8 study. Method of measurement: Ultra sonography. Values of kidney functional tests (Urea, Creatinin, BUN, Uric acid, Analysis of urinary ions (Ca, k, Na), Serum PTH). Timepoint: Before and after treatment. Method of measurement: Enzymatic methods, Atomic absorption, ELISA kit. Status of metabolic syndrome. Timepoint: Before and after treatment. Method of measurement: Measurement of blood pressure with stethoscope, Measurement of waist circumference , Measurement of HDL-cholesterol, triglyceride, FBS and fasting Insulin through enzymatic methods. Values of liver functional tests (ALT_AST_ALP). Timepoint: Before and after treatment. Method of measurement: Enzymatic methods. Urine culture status. Timepoint: Before and after treatment. Method of measurement: Standard methods. Dietary status (Dietary intake and Appetite). Timepoint: Before and after treatment. Method of measurement: FFQ and VAS questionnaires. Serum levels of oxidative Stress indices (Malondialdehyde (MDA) and Total antioxidant capacity). Timepoint: Before and after treatment. Method of measurement: Spectrophotometry. Status of some blood indices [PT(prothrombin time), ESR (erythrocyte sedimentation rate), INR (International Normalized Ratio), Albumin]. Timepoint: Before and after treatment. Method of measurement: Standard method, Westergren, Calculate, ELISA kit. Tabriz University of Medical Sciences Approved 2019-03-10 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Attar Neyshabouri Av., Golgasht St. tabriz East Azarbaijan Iran (Islamic Republic of)