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IRCT20210914052469N1 IRCT 2021-12-06 Tabriz University of Medical Sciences "Evaluation of the effect of boron on kidney stones" The effect of boron supplementation on nutritional status, kidney stone size, improvement of clinical symptoms and some of the serum and urine biomarkers in patients with nephrolithiasis: a randomized, double-blind, placebo-controlled trial 2021-11-22 anticipated 60 Complete https://irct.ir/trial/58730 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling is simple and available and the randomization tool will be random allocation software that in addition to simple randomization, this software will be able to random allocation by block method ( randomization Block) and randomly sequence the supplement or placebo. First, patients are blocked according to sex and then using block randomization method and blocks of four will be divided into two groups of intervention and placebo. To hide random allocation or not specify the type of intervention before assigning a person to a specific group, opaque sealed envelopes with random sequences will be used, in which each of the random sequences created on a card will be used. It is registered and the cards are placed in the letter envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. At the beginning of the registration of participants, according to the order of entry of participants, according to the order of entry of eligible participants to study, one of the envelopes is opened in order and the assigned group of the participant is revealed, Blinding description: 60 eligible patients will be randomly assigned to one of the intervention or control groups based on the blocks created by the random allocation software. The generated random sequence is kept in a safe place and performed by an independent third party who is blind to the trial during the study. 3 kidney stone. Intervention 1: Intervention group 1: Boron citrate, dose: 5 mg per capsule, number of times: twice a day, time of use: 2 months, Manufacturer: Nutrition Research Center and School of Pharmacy,Tabriz University of Medical Sciences. Intervention 2: Intervention group 2: Sodium tetrahydroborate, dose: 5 mg per capsule, number of times: twice a day, time of use: 2 months, Nutrition Research Center and School of Pharmacy,Tabriz University of Medical Sciences. Intervention 3: Control group: corn starch, dosage: 5 mg per capsule, number of times: twice a day, time of use: 2 months, Nutrition Research Center and School of Pharmacy,Tabriz University of Medical Sciences. Yes - There is a plan to make this available What will be shared: The data will be confidential but the results of the study will be published based on the article When: The access period starts 6 months after the results are published To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: The use of data is permitted for use in scientific research Where to obtain: To receive data by email, refer to ostadrahimi@tbzmed.ac.ir How to obtain: Requests should be emailed to ostadrahimi@tbzmed.ac.ir and information will be provided to the applicant within two weeks. Comments:
public Gita Vousoughi
No.64, Farvardin Alley.,North Khajeh Nasir Ave
Maragheh Iran (Islamic Republic of) 5516946418 +98 41 3746 1910 gitvous@yahoo.com Tabriz University of Medical Sciences scientific Alireza Ostad Rahimi
Faculty of Nutrition and Food Science, Attar Neyshabouri Ave., Golgasht Ave., Tabriz
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3746 1910 ostadrahimi@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with kidney stones in the age range of 20-65 years and willing to cooperate 20 years 65 years Both Age under 20 and over 65 years Pregnancy Breastfeeding Cardiovascular disease Bile stone Kidney failure Cancer Benign prostatic hyperplasia (BPH) Hypothyroidism or hyperthyroidism Urinary tract infection Estrogen therapy Egular use of vitamin supplements and herbal teas and Alcohol consumption N20 Calculus of kidney and ureter Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Boron citrate, dose: 5 mg per capsule, number of times: twice a day, time of use: 2 months, Manufacturer: Nutrition Research Center and School of Pharmacy,Tabriz University of Medical Sciences. Intervention group 2: Sodium tetrahydroborate, dose: 5 mg per capsule, number of times: twice a day, time of use: 2 months, Nutrition Research Center and School of Pharmacy,Tabriz University of Medical Sciences. Control group: corn starch, dosage: 5 mg per capsule, number of times: twice a day, time of use: 2 months, Nutrition Research Center and School of Pharmacy,Tabriz University of Medical Sciences. Kidney stone size. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Ultrasound. Improve clinical symptoms. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Questionnaire. Anthropometric indicators include: weight, height, waist circumference, hip circumference. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Weight is measured using a Seca calibrated scale with an accuracy of 0.1 kg and with a minimum of clothing in the early morning in the form of fasting and measuring height, waist circumference and hip circumference using a tape measure with an accuracy of 0.1 cm. Serum levels of ionized calcium, phosphorus, uric acid, urea, creatinine and alkaline phosphatase. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: At the beginning and end of the study, fasting blood samples will be taken from all participants after 8-12 hours of fasting in the central laboratory of Maragheh. Determination of serum level of the studied variables is done according to the relevant protocol. Also, part of the serum sample is stored in a freezer at -70 degrees. Urine analysis (measurement of citrate and oxalate and urinary calcium and general urinalysis). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: At the beginning and end of the study, random urine samples will be taken from all participants in Maragheh Central Laboratory and urine analysis will be performed. Body composition measurements include fat mass, lean body mass, total body water. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Using the BIA (Bioelectric Impedance Analyser) device, fasting (10-12 hours fasting) hs done. Tabriz University of Medical Sciences Approved 2021-10-25 Ethics committee of Tabriz University of Medical Sciences third house from the left, Oval dead end from the right, Ghaem Alley, Etihad Alley, 20 meters from Etihad Alley, Pasdaran St Maraghe East Azarbaijan Iran (Islamic Republic of)