This study is double blind, placebo clinical controlled trial(Randomization and allocation will hide from the researcher and patients until the main analyses were completed). Diabetic hemodialysis patients form at the Imam Ali Dialysis Center (Zahedan, Iran) will randomly divided into 2 groups (case=20, control=20) to receive 220 mg Zinc sulfate (containing 50 mg zinc) supplements or placebo (220-mg corn starch). Blood samples were taken at baseline and after 56 days intervention to quantify serum galectin-3 level.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Diabetic hemodialysis patients; Age:15-70 years; Pass at least 6 months from hemodialysis; Not having inflammatory diseases affecting on serum inflammatory markers; Not consuming supplements containing antioxidants, Zinc supplement, vitamins E and C supplements and Steroidal and Non-Steroidal Anti-Inflammatory drugs(NSAIDs) one month before the start of the study. Non-inclusion criteria: Consumption of Antibiotics or existence of infectious and feverish illnesses one month before starting the study; Existence of diseases affecting serum galectin-3 such as cardiovascular disease
Intervention groups
Intervention group1: Diabetic hemodialysis patients who will receive 220mg Zinc sulfate capsule (n=20) manufactured by Alhavi Pharmaceutical Company (Tehran, Iran), once a day for 56 days.
Control-group:Diabetic hemodialysis patients (n=20) who will receive a placebo capsule (220mg corn starch) manufactured by Alhavi Pharmaceutical Company (Tehran, Iran), for 56 days.
Main outcome variables
Galectin-3
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191217045765N1
Registration date:2020-02-09, 1398/11/20
Registration timing:retrospective
Last update:2020-02-09, 1398/11/20
Update count:0
Registration date
2020-02-09, 1398/11/20
Registrant information
Name
Mansour Karajibani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 6797
Email address
mkarajibani@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Zinc sulfate consumption on serum Galectin-3 level in Diabetic Hemodialysis patients
Public title
Effect of Zinc sulfate in Diabetic Hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic Hemodialysis patients
Age:15-70 years old
Pass at least 6 months from hemodialysis
Not having inflammatory diseases affecting on serum inflammatory markers
Not consuming supplements containing antioxidants, Zinc supplement, vitamins E and C supplements and Steroidal and Non-Steroidal Anti-Inflammatory drugs(NSAIDs) one month before the start of the study
Exclusion criteria:
Consumption of antibiotics or existence of infectious and feverish illnesses one month before starting the study
Existence of diseases affecting serum galectin-3 such as cardiovascular disease
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Diabetic Hemodialysis patients with inclusion criteria enter as available. Then they will be divided into two groups(case and control) using the file number through random variable.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will hide from the researcher and patients until the main analyses were completed
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Zahedan University of Medical Sciences
Street address
Dr Hesabi Sq; Khalije Fars Blvd; Zahedan; Iran.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-12-08, 1398/09/17
Ethics committee reference number
IR.ZAUMS.REC.1398.330
Health conditions studied
1
Description of health condition studied
Diabetic Hemodialysis
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
Serum galectin-3
Timepoint
Before and after 8-week intervention
Method of measurement
It measured by ELISA method with standard kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: The zinc-supplementation group(n=20) will receive a 220-mg Zinc sulfate capsule (containing 50 mg zinc) manufactured by Alhavi Pharmaceutical Company (Tehran, Iran); for 56 days.
Category
Treatment - Drugs
2
Description
Control group:The control-group(n=20) will receive a placebo capsule(220-mg corn starch), for 56 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Dialysis Center
Full name of responsible person
Dr Elham Shahraki
Street address
Imam Ali Hospital; Salamat Blvd; khalije Fars High road
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43111
Phone
+98 54 3329 5564
Email
shahrekie@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Nour Mohammad Bakhshani
Street address
Dr Hesabi Sq; Khalije Fars Blvd; Zahedan; Iran.
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
nmbakhsha@zdmv.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Dr mansour karajibani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No, 34, 31th University Ave, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98168-46115
Phone
+98 54 3342 0670
Email
mkarajibani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Mansour Karajibani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No34, 31th University Ave, Zahedan,Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98168-46115
Phone
+98 54 3342 0670
Email
mkarajibani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Razieh Hosseini
Position
MS.c of Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No 9, Shariati Ave, Nour Abad, Fars, Iran
City
Nour Abad Mammasani
Province
Fars
Postal code
73517-38177
Phone
+98 71 4252 0479
Email
razieh.hosseini7759@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