Evaluation of the Effect of Zinc Prescription on Hemoglobin Level and Erythropoetin Dose Requirement in Hemodialysis Patients in comparison with Placebo
Determining the effect of zinc supplement on hemoglobin level in hemodialysis patients before, 3 and 6 months after beginning of the study in 2 groups of intervention and placebo.
Design
Randomized double blind, parallel group, controlled clinical trial, design of 30 patients, randomization is done by permuted block randomization of blocks size 4.
Settings and conduct
In this randomized double blind parallel groups design Hemodialysis patients who attended in Al- Zahra and Khorshid hospitals who fulfill the inclusion criteria will be invited and among them 30 who agree to participate in our study are selected and randomly divided into 2 groups (intervention and control). Intervention group receive zinc tablet and control group receive placebo. Hemoglobin level, serum zinc level and erythropoetin dose are checked before the study, 3 months and 6 months after the beginning of the study. Patient, investigator and health care workers are blinded. Drug and placebo are prepared in similar boxes while differentiated by labels A and B, by a person outside the study.
Participants/Inclusion and exclusion criteria
1- Hemodialysis patients
2- Hemoglobin level less than 12 g/dl
3- Ongoing therapy with injected erythropoetin
4- Consensus on participation in the study
5- Non pregnant and breastfeeding
6- Not having malignancy, inflammatory and severe hepatic diseases
Intervention groups
Patients randomly divided into two groups: 1- DRUG 2- PLACEBO. In DRUG group patients receive one tablet of 30 mg zinc daily for 6 months and in PLACEBO group patients receive one tablet of placebo daily for 6 months also.
Serum zinc level will be measured before, 3 months and 6 months after receiving zinc or placebo in both groups.
Main outcome variables
Hemoglobin level,
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200827048539N1
Registration date:2020-10-19, 1399/07/28
Registration timing:prospective
Last update:2020-10-19, 1399/07/28
Update count:0
Registration date
2020-10-19, 1399/07/28
Registrant information
Name
Shiva Seirafian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3822 7000
Email address
seirafian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Zinc Prescription on Hemoglobin Level and Erythropoetin Dose Requirement in Hemodialysis Patients in comparison with Placebo
Public title
The Effect of Zinc on Hemoglobin in Hemodialysis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have been on hemodialysis for at least 3 months
More than 18 years of age
Consensus on participation in the study
Hemoglobin level less than 12 g/dl
Patients who are under ongoing therapy with injected erythropoetin
Not taking cholrthalidone, tetracycline and penicillin
Non pregnant and breastfeeding
On hemodialysis for at least twice a week
Not having cancer, acute inflammatory disease and severe hepatic failure
Exclusion criteria:
Patients wanting to discontinue the cooperation for any reason
Discontinuing hemodialysis therapy
Surgical operation during the study
Blood transfusion during the study
Hemorrhage during the study
Development of malignant tumors during the study
Pregnancy during the study
Intolerance of drug
Non-compliance with the intervention (less than 70%)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation in current study will be done using permuted block randomization of block size 4, and each patient is as a unit of randomization, and random sequence generation will be done using statistical software and will be conducted using sealed envelops.
Blinding (investigator's opinion)
Double blinded
Blinding description
All the patients, investigators, health care workers and drug prescribers will be blinded. Drug and placebo will be prepared in simple and similar boxes by a trained person who is not in the study, does not work in the dialysis ward and does not have any relations with any of the people in the study group or health care workers. Drug and placebo are marked by labels A and B in similar boxes. Then they are shared by health care workers who have no contact with the divider of the drug. This drug A and B are randomly distributed among patients who have been sampled randomly. The test results and other data are gathered by the investigators. Only data analyzer is informed about drug A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Vice-Chancellery for Research and Technology, Isfahan University of Medical Sciences, Hezar Jerib Street,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-08-25, 1399/06/04
Ethics committee reference number
IR.MUI.MED.REC.1399.432
Health conditions studied
1
Description of health condition studied
End stage renal disease on hemodialysis
ICD-10 code
Z99.2
ICD-10 code description
Dependence on renal dialysis
2
Description of health condition studied
Anemia
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
Blood hemoglobin level
Timepoint
Before, 3 and 6 months after the intervention
Method of measurement
Hemoglobin measurement by automated hematology analyzer, sysmex-21N, Japan
Secondary outcomes
1
Description
The amount of prescribed erythropoetin
Timepoint
Before, 3 and 6 months after the intervention
Method of measurement
By observation and questionnaire
2
Description
Serum zinc level
Timepoint
Before, 3 and 6 months after the intervention
Method of measurement
Laboratory AUDIT kit (Delta Darman Part, Tehran, Iran), measured by OLYMPUS 2700 autoanalyzer, Japan
Intervention groups
1
Description
Intervention group: 30 hemodialysis patients enroll in the study using 30 mg zinc gluconate tablets containing 30 mg elemental zinc (Dineh pharmaceutical Co., Tehran, Iran). The patients are taught to take one tablet with water after breakfast; and on dialysis days, after the meal post dialysis session; daily for 6 months. The drug will be offered in hemodialysis ward weekly and to make sure the drug is taken by the patients, they are asked to return the empty box.
Category
Treatment - Drugs
2
Description
Control group: 30 hemodialysis patients enroll in the study and will receive the placebo with the same size, smell, color and packaging produced by Isfahan Faculty of Pharmacy. The patients are taught to take the placebo with water daily after breakfast, and on dialysis days after the meal post dialysis session; for 6 months. The patients will receive the placebo in hemodialysis wards weekly and to make sure the drug is taken by the patients, they are asked to return the empty box.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Shiva Seirafian
Street address
Shahid Keshvary Highway, Soffeh Blvd.,
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 2664
Email
seirafian@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Noor-Aliasghar hospital
Full name of responsible person
Elham Kabiri Naeini
Street address
Hashtbehesht Ave., Ostandari Street,
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2127
Email
kabirielham20@gmail.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
Vice-Chancellor for Research and Technology, No. 4 Bluid., Isfahan University of Medical Sciences, Hezar Jerib street,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Fax
+98 31 3668 5149
Email
research@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
Shiva Seirafian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Adult Nephrology
Street address
Isfahan Kidney Diseases Research Center, Al-Zahra Hospital, Soffeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 2664
Email
seirafian@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shiva Seirafian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Isfahan Kidney Diseases Research Center, Al-Zahra Hospital, Soffeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 2664
Email
seirafian@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham Kabiri Naeini
Position
Nephrology fellow
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Isfahan Kidney Diseases Research Center, Al-Zahra Hospital, Soffeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 2664
Fax
+98 31 3620 2088
Email
kabirielham20@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
Yes - There is 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
1- Primary outcome including hemoglobin level in two groups of intervention
2- Secondary outcome including erythropoetin dose changes in two groups of intervention
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Academic persons only can apply to receive it.
Under which criteria data/document could be used
1- Compare with or add to similar data of other studies 2- Doing statistical analysis other than we did provided that the right of first investigators be preserved.
From where data/document is obtainable
By e-mail: seirafian@med.mui.ac.ir
What processes are involved for a request to access data/document
One month after receiving inquiry, email and mobile number, it will be responsed.