Determination of nephroprotective effect of lycopene in patients receiving vancomycin
Design
A clinical trial with an intervention groups and one control group, in parallel, double blinded, simple randomized groups and sample size of 60
Settings and conduct
This study is performed on patients at Alzahra Hospital. The subjects will be randomly assigned to two groups: lycopene and control. For people in the case group, lycopene tablets 15 mg once a day and for the control group placebo at the same dose accompanying vancomycin will be prescribed. Before starting treatment, every other day during treatment and 12 hours after the last dose of vancomycin on the tenth day of treatment with this antibiotic, blood samples were taken from both groups of patients and serum creatinine and blood urea nitrogen levels will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Serum creatinine levels less than 1.2 mg/dl at the start of the study; Creatinine clearance (ClCr)>90 ml / min upon admission; Lack of underlying renal impairment; Lack of underlying diseases causes kidney disorders such as diabetes mellitus and high blood pressure; Hospital history and failure to receive other nephrotoxic drugs such as aminoglycosides, amphotericin B, cyclosporine, tacrolimus and furosemide, etc; Do not take other antioxidant supplements such as vitamins C and E; Exclusion criteria: History of acute kidney damage; Lycopene allergy history; History of injectable addiction
Intervention groups
The subjects are randomly divided into two groups. The first group will receive lycopene, made by the 21st century factory, at a dose of 15 mg once daily, and the control group will receive placebo, which is made from starch and lactose by the Isfahan School of Pharmacy, at the same dose as lycopene and vancomycin.
Evaluation of the nephroprotective effect of lycopene in patients receiving vancomycin
Public title
Lycopene nephroprotective effect in patients receiving vancomycin
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Serum creatinine levels less than 1.2 mg / dl at the start of the study
Creatinine clearance (ClCr)> 90 ml / min upon admission
Lack of underlying renal impairment such as glomerulonephritis, polycystic kidney disease, kidney stones, interstitial nephritis, renal artery stenosis and renal carcinoma
Lack of underlying diseases causes kidney disorders such as diabetes mellitus and high blood pressure
Hospital history and failure to receive other nephrotoxic drugs such as aminoglycosides, amphotericin B, cyclosporine, tacrolimus and furosemide, etc.
Do not take other antioxidant supplements such as vitamins C and E.
Exclusion criteria:
History of acute kidney damage
Lycopene allergy history
History of injectable addiction
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Since the total sample size is 60 people, 15 blocks of 4 were defined and 6 different modes of blocks were considered. Then, by determining random numbers by computer, the order of blocks was determined and finally the process of sampling was based on the obtained sequences.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind, none of the patients and the outcome assessor were aware of the type of group therapy received by the patients until the end of study. The treatment pills were in two groups as closed packs with codes A and B, which were assigned to group A packs containing code A and to group B packs with code B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahn University of Medical Sciences, Hezar Jarib st, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2019-05-25, 1398/03/04
Ethics committee reference number
IR.MUI.MED.REC.1398.104
Health conditions studied
1
Description of health condition studied
Vancomycin-induced nephrotoxicity
ICD-10 code
N14.4
ICD-10 code description
Toxic nephropathy, not elsewhere classified
Primary outcomes
1
Description
Serum creatinine
Timepoint
Before starting treatment, one day between treatments and 12 hours after the last dose of vancomycin on the tenth day of treatment
Method of measurement
Photometric
2
Description
Blood urea nitrogen
Timepoint
Before starting treatment, one day between treatments and 12 hours after the last dose of vancomycin on the tenth day of treatment
Method of measurement
Photometric
3
Description
Creatinine clearance
Timepoint
Before starting treatment, one day between treatments and 12 hours after the last dose of vancomycin on the tenth day of treatment
Method of measurement
Cockcroft-Gault formula
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For people in the case group, lycopene tablets 15 mg with vancomycin will be prescribed once a day.
Category
Treatment - Drugs
2
Description
Control group: For control group participants, placebo tablets 15 mg with vancomycin will be prescribed once a day.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra hospital
Full name of responsible person
Somaye Haghighipour
Street address
Sofe Blvd, Isfahan Province, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3653 1498
Email
s_haghighipour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical Sciences, Hezar Jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Somaye Haghighipour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3653 1498
Email
s_haghighipour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Somaye Haghighipour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3653 1498
Email
s_haghighipour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Somaye Haghighipour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3653 1498
Email
s_haghighipour@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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