The effect of zinc supplementation on inflammatory factor CRP and NLR in patients with renal failure undergoing hemodialysis
Measurement of serum zinc levels in hemodialysis patients
Measurement of serum CRP levels in hemodialysis patients
Measurement of NLR in hemodialysis patients
using KDQOL-SF1.3 (Kidney Disease Quality of Life Short Form)questionnaire
Design
The study is a double-blind prospective randomized clinical trial in crossover form. The number of 40 patients (48 patients including 20% dropout) are randomly divided into two groups of 24 cases.
Settings and conduct
Before the start of the first dose of the drug, blood samples are taken from the patients, and the level of serum zinc and the quality of life are recorded by KDQOL-SF 1.3 questionnaire and other investigated factors. After 30 days and at the end of the study (60 days), all aspects will be measured and compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-People over 18 years old
2-Zinc level less than 70 mcg / dL
3-Has been on regular hemodialysis for at least six months
4-Undergo hemodialysis at least twice a week.
Exclusion criteria:
1-Patient dissatisfaction
2-The patient hospitalized for the last three months
3-Use of zinc supplement during the previous two weeks (use of specific multivitamins for dialysis patients is not concluded)
4-Use of selenium supplement in the last two weeks
Intervention groups
After obtaining informed consent from the patients, the first group will be given 50 mg of zinc (one tablet) daily for 30 days, and the second group will receive a placebo tablet. After 30 days, the first group will be given the placebo, and the second group will be assigned 50mg of zinc (one tablet) daily for 30 days.
Main outcome variables
CRP,NLR(neutrophil lymphocyte ratio)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160412027346N8
Registration date:2022-08-02, 1401/05/11
Registration timing:prospective
Last update:2022-08-02, 1401/05/11
Update count:0
Registration date
2022-08-02, 1401/05/11
Registrant information
Name
Shadi Ziaie
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
shadiziaie@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-27, 1401/06/05
Expected recruitment end date
2022-10-27, 1401/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effect of Zinc supplement on CRP and NLR inflammatory factor in MHD patients
Public title
Evaluating the Effect of Zinc supplement on CRP and NLR inflammatory factor in MHD patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People over 18 years old
Zinc level less than 70 mcg/ dL
Has been on regular hemodialysis for at least 6 month
Undergo hemodialysis at least twice a week
Exclusion criteria:
Patient dissatisfaction
Have been hospitalized for the last 3 months
Use of zinc supplement in the last two weeks (use of specific multivitamins for dialysis patients is not recommended)
Use of selenium supplement in the last two weeks
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The drug and placebo were precisely identical in shape and appearance and prepared in similar packaging. A specific code was assigned to the placebo and a code to the drug. Furthermore, it is presented to the patients according to the randomization table. Only the principal investigator will know the code of the drugs. Medicines are given to patients by ward nurses who do not know the code of medicines.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug and the placebo are in a package with a standard label and the same amount, and each box is assigned a code that is only available to the researcher, depending on whether it is a drug or a placebo.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Tehran Province, Tehran, Velenjak, Arabi Ave
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2022-03-09, 1400/12/18
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.004
Health conditions studied
1
Description of health condition studied
End stage kidney disease under hemodialysis
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
The effect of zinc supplementation on CRP
Timepoint
The beginning of the study, 30 and 60 days
Method of measurement
Laboratory test
Secondary outcomes
1
Description
The effect of zinc supplementation on NLR (nutrophil,lymphocyte ratio)
Timepoint
The beginning of the study, day 30 and 60
Method of measurement
laboratory test
Intervention groups
1
Description
Intervention group: Administration of 50 mg zinc sulfate tablets - once a day - orally - for one month - manufactured by Alhawi company
Category
Treatment - Drugs
2
Description
Control group: Administration of placebo - once a day - orally
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Labbafinejad Medical center
Full name of responsible person
Dr Shadi Ziaie
Street address
9th Boostan Pasdaran St Tehran
City
Tehran
Province
Tehran
Postal code
5546859685
Phone
+98 21 23601
Email
Shadiziaie@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Nima Naderi
Street address
Niayesh Highway, Valiasr Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
school.pharmacy@sbmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shayan Mastoor Tehrani
Position
Clinical pharmacy resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
school of pharmacy, Niayesh crossroad, Vali-asr st.
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
Sh.M.Tehrani@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Shadi Ziaie
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
9th Boostan, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
2356987452
Phone
+98 21 2361
Email
shadiziaie@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shayan Mastoor Tehrani
Position
Clinical pharmacy resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
school of pharmacy, Niayesh crossroad, Vali-asr st.
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
Sh.M.Tehrani@sbmu.ac.ir
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
At the end of the study of all patient data, after making them non-identifiable and performing the statistical analysis mentioned in the work method, necessary reports will be extracted and a part of it related to the main outcome will be shared.
When the data will become available and for how long