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The effects of sodium pentaborate (NaB) supplementation on calculi status and related metabolic risk factors in patient with kidney stone

Protocol summary

Study aim
To determine effects of sodium pentaborate (NaB) supplementation on calculi status and related metabolic risk factors in patient with kidney stone.
Design
In this double blind randomized controlled trial with two parallel groups, 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.
Settings and conduct
After registration of clinical trial, the researcher will identify the eligible individuals. All eligible persons who are willing to participate at the study will sign a written consent form, and afterward questionnaires will be complete. Ten ml of fasting blood sample will be taken for laboratory. Supplements and their placebo will be prepared in identical appearance. Participants and researchers will be blind.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Men and women aged 20-50 years; Patients with kidney stones with urologist diagnosis; 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. Non-inclusion Criteria: Pregnancy or lactation; Suffering from other kidney related metabolic disorders and disease at the same time; Patients with obstructive, infectious, and ureter stones; and Emergency cases requiring special treatment or surgery with the diagnosis of urologists.
Intervention groups
The groups will receive sodium pentaborate or placebo (carboxymethyl cellulose) capsules 5 mg twice daily (every 12 hours) for 8 weeks.
Main outcome variables
Calculi status, Status of cardio-vascular disease and metabolic syndrome risk factors (Blood pressure, Anthropometric measures, Lipid profile, Fasting Blood glucose), kidney functional tests (Urea, Creatinin, BUN, Uric acid, Analysis of urinary ions (Ca, k, Na), Serum PTH)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090609002017N34
Registration date: 2019-04-07, 1398/01/18
Registration timing: prospective

Last update: 2019-04-07, 1398/01/18
Update count: 0
Registration date
2019-04-07, 1398/01/18
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-21, 1398/03/31
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of sodium pentaborate (NaB) supplementation on calculi status and related metabolic risk factors in patient with kidney stone
Public title
The effects of sodium pentaborate (NaB) supplementation on calculi status and related metabolic risk factors in patient with kidney stone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Attar Neyshabouri Av., Golgasht St.
City
tabriz
Province
East Azarbaijan
Postal code
5166/1573113
Approval date
2019-03-10, 1397/12/19
Ethics committee reference number
IR.TBZMED.REC.1397.1023

Health conditions studied

1

Description of health condition studied
kidney stone
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter

Primary outcomes

1

Description
Calculi status
Timepoint
Weeks 0, 4 and 8 study
Method of measurement
Ultra sonography

2

Description
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

3

Description
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

Secondary outcomes

1

Description
Values of liver functional tests (ALT_AST_ALP)
Timepoint
Before and after treatment
Method of measurement
Enzymatic methods

2

Description
Urine culture status
Timepoint
Before and after treatment
Method of measurement
Standard methods

3

Description
Dietary status (Dietary intake and Appetite)
Timepoint
Before and after treatment
Method of measurement
FFQ and VAS questionnaires

4

Description
Serum levels of oxidative Stress indices (Malondialdehyde (MDA) and Total antioxidant capacity)
Timepoint
Before and after treatment
Method of measurement
Spectrophotometry

5

Description
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

Intervention groups

1

Description
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)
Category
Treatment - Drugs

2

Description
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.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Nutrition Research Center, Tabriz University of Medical Sciences,
Full name of responsible person
Dr. Alireza Ostadrahimi
Street address
Attar Neyshaburi Ave, Golgasht St, Nutrition Faculty.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
nut-rc@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolghasem Jouyban
Street address
No. 2 Central building of the university, Golgasht street, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Behrooz
Position
Ph.D. Candidate in Nutritional Sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Attar Neyshabouri Av., Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
mm.behroozp@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Ostadrahimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attar Neyshaburi Ave, Golgasht St, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
ostadrahimi@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Behrooz
Position
Ph.D. Candidate in Nutritional Sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attar Neyshaburi Ave, Golgasht St, Tabriz, Ira
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7582
Email
mm.behroozp@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data collected for the primary outcomes will be shared.
When the data will become available and for how long
access starting 12 months after publication
To whom data/document is available
The data will only be available for people working in academic institution.
Under which criteria data/document could be used
The data of the present study will only be accessible by other researchers, for conducting Meta-analysis
From where data/document is obtainable
To access the required data, the researchers can contact Dr.alireza ostadrahimi. E-mail address: ostadrahimi@tbzmed.ac.ir
What processes are involved for a request to access data/document
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.
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