Evaluation of The effect of oral zinc on nutritional and inflammatory factors in chronic hemodialysis patients in Booali hospital
Design
randomized clinical trial with control group.single blind
Settings and conduct
The trial was conducted at Boo Ali Hospital in Tehran and randomly divided into two groups of intervention and control.
Participants/Inclusion and exclusion criteria
inclusion criteria:hemodialysis patients consent to participate in study
Exclusion criteria:Patients receiving tetracycline and quinolone.
Intervention groups
The intervention group consisted of patients who received two capsules of 110 mg zinc sulfate daily along with their other medications for 3 months.
The control group consisted of patients who received 2 capsules of 110 mg zinc sulfate daily along with their other medications for 3 months.
The effect of oral zinc on nutritional and inflammatory factors in chronic hemodialysis patients
Public title
Evaluation of the effect of oral zinc in patients with chronic hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hemodialysis patients consenting to participate in the study
Exclusion criteria:
Patients receiving tetracycline and quinolone.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
2
Patient serum sample
Actual sample size reached:
80
More than 1 sample in each individual
Actual sample size in each individual:
2
Patient serum sample
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Method:Simple randomization Randomization tool: Random Number Table
Blinding (investigator's opinion)
Single blinded
Blinding description
All patients who were included in the study were randomly assigned to either drug or placebo groups by random number table. Patients were unaware of the drug or placebo intervention.But the researcher and the doctor were aware of the drug or placebo.Patients and medications were coded by the researcher.The blinding was such that the placebo was the same color and flavor as the drug. That is, the drug and the placebo were both similar in appearance.But the placebo capsules contained cornstarch.
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Department of Pharmaceutical Sciences, Tehran Islamic Azad University of Medical
Street address
Dr Shariati Ave., Gholhak, Yakhchal Ave., Islamic Azad University of Pharmaceutical Sciences Branch
City
Tehran
Province
Tehran
Postal code
193956466
Approval date
2019-01-05, 1397/10/15
Ethics committee reference number
IR.IAU.PS.REC.1397.324
Health conditions studied
1
Description of health condition studied
Inflammation and malnutrition in patients with chronic hemodialysis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
HBA1C
Timepoint
Before the start of the study and three months after taking oral zinc tablets
Method of measurement
Variable serum levels were measured by chromatography
2
Description
Albumin
Timepoint
Before the start of the study and three months after taking oral zinc tablets
Method of measurement
The serum levels of the variable were measured by Bromocresol Green.
3
Description
BUN or blood urea nitrogen
Timepoint
Before the start of the study and three months after taking oral zinc tablets
Method of measurement
Serum levels of variable blood were measured by tacophoresis.
4
Description
Hemoglobin
Timepoint
Before the start of the study and three months after taking oral zinc tablets
Method of measurement
Serum levels of variable blood were measured by cyanometho hemoglobin.
5
Description
Triglycerides
Timepoint
Before the start of the study and three months after taking oral zinc tablets
Method of measurement
The serum levels of the variable blood were measured by a special kit using triglyceride oxidase.
6
Description
ESR or erythrocyte sedimentation rate
Timepoint
Before the start of the study and three months after taking oral zinc
Method of measurement
The serum level of the variable in question was measured by the Westergreen method.
7
Description
ferritin
Timepoint
Before the start of the study and three months after taking oral zinc
Method of measurement
Serum levels of variable blood were measured by RIA.
8
Description
CRP or C reactive protein
Timepoint
Before the start of the study and three months after taking oral zinc
Method of measurement
Blood serum levels of the variable were measured with special latex agglutination kits.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The group received 2 capsules of zinc sulfate 110 mg daily along with their other medications.
Category
Treatment - Drugs
2
Description
Control group: The group received 2 placebo capsules of zinc sulfate 110 mg daily along with their other medications.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Booali Hospital, Tehran
Full name of responsible person
Dr.farahnaz pasha
Street address
Tehran - Imam Hossein Square - At the beginning of Damavand Street
City
tehran
Province
Tehran
Postal code
17117
Phone
+98 21 3334 8036
Fax
Email
booali.hospital96@gmail.com
Web page address
http://bouali.iautmu.ac.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.farshad hashemian
Street address
Tehran. Islamic Azad University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Fax
+98 21 2260 0714
Email
info@iau.ac.ir
Web page address
http://iaups.iautmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Student herself
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
hanieh bahrami tabar
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Kangavar, Taleghani Street, the end of Keshavarzi Bank Alley
City
kangavar
Province
Kermanshah
Postal code
6741713445
Phone
+98 83 4822 1456
Email
hanieh.bahramitabar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
maryam shiehmorteza
Position
Doctor of Pharmacotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Dr Shariati St., Gholak St., Islamic Azad University of Pharmaceutical Sciences
City
tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Email
shiehmorteza@iaups.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
hanieh bahrami tabar
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Kangavar, Taleghani Street, the end of Keshavarzi Bank Alley
City
kangavar
Province
Kermanshah
Postal code
6741713445
Phone
+98 83 4822 1456
Email
hanieh.bahramitabar@gmail.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