"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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210914052469N1

Enrollment

Registered

2021-12-06

Start date

2021-11-22

Completion date

Unknown

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney stone. Calculus of kidney and ureter

Interventions

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

Eligibility

Sex/Gender

All

Age

20 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with kidney stones in the age range of 20-65 years and willing to cooperate

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactGita Vousoughi

Tabriz University of Medical Sciences

gitvous@yahoo.com+98 41 3746 1910

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026