This study is double blind, placebo controlled clinical trial; Patients and nurses and statistics Adviser do not know about the drug and placebo. 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) per day for 8 weeks. Fasting blood samples were taken at baseline and after 8 weeks’ intervention to quantify copeptin`, CRP and insulin. Also for determining nutritional status the Food Frequency Questionnaire will be completed by expert before and after 8-week intervention.
Participants/Inclusion and exclusion criteria
Diabetic hemodialysis patients(Pass at least 6 months from hemodialysis); Age:15-70; Not having inflammatory diseases affecting on serum inflammatory markers; One month before the study began no supplements containing antioxidants, Zinc supplement,vitamins E and C supplements; Steroid and non-steroidal anti-inflammatory drugs should not be used.
If the patients have been taking antibiotics for the past month and with infectious or feverish disease. Also diseases affecting on serum copeptin like severe cardiovascular disease, hypothyroidism, hyperthyroidism and sepsis are not included in this study.
Intervention groups
Diabetic hemodialysis patients in the zinc-supplementation group will receive a 220mg zinc sulfate capsule(n=20) manufactured by Alhavi Pharmaceutical Company (Tehran, Iran) and the control-group(n=20) will receive a placebo capsule(220mg corn starch), for 56 days.
Main outcome variables
Copeptin; Insulin; CRP;Nutritional status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190806044461N1
Registration date:2019-08-23, 1398/06/01
Registration timing:registered_while_recruiting
Last update:2019-08-23, 1398/06/01
Update count:0
Registration date
2019-08-23, 1398/06/01
Registrant information
Name
Razieh Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4252 0479
Email address
razieh.hosseini7759@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of zinc sulfate on serum copeptin, C-Reactive protein, insulin resistance and nutritional status in diabetic hemodialysis patients
Public title
Effect of zinc sulfate in diabetic hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic hemodialysis patients(Pass at least 6 months from hemodialysis); Age:15-70; Not having inflammatory diseases affecting on serum inflammatory markers; One month before the study began no supplements containing antioxidants,zinc supplement,vitamins E and C supplements; Steroid and non-steroidal anti-inflammatory drugs should not be used.
Exclusion criteria:
If the patients have been taking antibiotics for the past month and with infectious or feverish disease. Also Diseases affecting serum copeptin like severe cardiovascular disease, Hypothyroidism ,hyperthyroidism and sepsis are not included in this study.
Age
From 15 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
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
Patients and nurses ward and statistics Adviser do not know about the drug and placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of medical sciences
Street address
No. 9, Dr shariati Ave.
City
Nour Abad
Province
Fars
Postal code
73517-38177
Approval date
2019-07-21, 1398/04/30
Ethics committee reference number
IR.ZAUMS.REC.1398.207
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Serum copeptin
Timepoint
Before and after 8-week intervention
Method of measurement
It measured by ELISA method with standard kit
2
Description
Serum insulin
Timepoint
Before and after 8-week intervention
Method of measurement
It measured by ELISA method with standard kit
3
Description
C-Reactive-Protein
Timepoint
Before and after 8-week intervention
Method of measurement
It measured by ELISA method with standard kit
4
Description
Nutritional status
Timepoint
Before and after 8-week intervention
Method of measurement
Food Frequency Questionnaire
Secondary outcomes
1
Description
Insulin resistance
Timepoint
Before and after 8-week intervention.
Method of measurement
Homeostasis model assessment measuring insulin resistance
Intervention groups
1
Description
Intervention group: 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 8 weeks.
Category
Treatment - Drugs
2
Description
Control group:The control-group(n=20) will receive a placebo capsule(220-mg corn starch), for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Dialysis Center
Full name of responsible person
Elham shahreki
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
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
Razieh Hosseini
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No 9; Dr Shariati Ave.
City
Nour Abad Mammasani
Province
Fars
Postal code
73517-38177
Phone
+98 71 4252 0479
Email
razieh.hosseini7759@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Razieh Hosseini
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No 9; Dr Shariati Ave
City
Nour Abad Mammasani
Province
Fars
Postal code
73517-38177
Phone
+98 71 4252 0479
Email
razieh.hosseini7759@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Razieh Hosseini
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No 9; Dr Shariati Ave
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