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

Determining the effect of boron supplementation on nutritional status, size of kidney stones, improvement of clinical symptoms and some biochemical indicators of serum and urine in patients with kidney stones

Clinical trial with control group, with parallel groups, double-blind, randomized, on 60 patients, RAS software was used for randomization.

This study will be performed on 60 patients in the clinics of Maragheh city and the packaging and coding of placebo capsules and the main supplement was done by a person outside the project and the prescriber of the supplement and the doctor reviewing the results of the project and other researchers. It does not matter which is a placebo or a supplement

Inclusion criteria: Patients with kidney stones in the age range of 20-65 years and willing to cooperate Non-entry conditions: under 20 and over 65 years, pregnancy, lactation, cardiovascular disease, liver disease, gallstone, kidney failure, cancer, benign prostatic hyperplasia (BPH), hypothyroidism or hyperthyroidism, urinary tract infection , Estrogen therapy and regular consumption of vitamin supplements and herbal teas and alcohol consumption

Intervention group 1: includes 20 people with kidney stones with inclusion criteria who will receive 10 mg of boron citrate supplement daily. Intervention group 2: including 20 people with kidney stones with inclusion criteria who will receive 10 mg of sodium tetrahydroborate daily. Control group: including 20 people with kidney stones with inclusion criteria who will receive 10 mg placebo daily containing corn starch.

Anthropometric Indices؛ body composition؛ Kidney stone size؛ clinical signs؛ ionized calcium, uric acid, urea, creatinine and alkaline phosphatase, urinary citrate and oxalate calcium and general urinalysis

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.

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.

The data will be confidential but the results of the study will be published based on the article

The access period starts 6 months after the results are published

The data will be available only to researchers working in academic and scientific institutions

The use of data is permitted for use in scientific research

To receive data by email, refer to ostadrahimi@tbzmed.ac.ir

Requests should be emailed to ostadrahimi@tbzmed.ac.ir and information will be provided to the applicant within two weeks.