Protocol summary
-
Study aim
-
The aim of this randomized, placebo-controlled trial is to investigate the effects of zinc supplementation on serum levels of brain derived neurotrophic factor(BDNF), vascular endothelial growth factor(VEGF), advanced glycation end products, Matrix Metalloproteinas 9 and caspase 3 in diabetic retinopathy patients.
-
Design
-
randomised trial with control group, parallel group, two side blinded
-
Settings and conduct
-
The participants will be assigned into control and treatment groups using permuted-blocks randomization. This reception would be for 3 months one to two hours after lunch.
-
Participants/Inclusion and exclusion criteria
-
Fifty diabetic retinopathy patients that their disease was confirmed by pathologic assessment will include in this study according inclusion ( like Subject diagnosed with diabetic retinopathy) and exclusion ( like Insulin injection; Having chronic diseases such as cardiovascular disorders) criteria.
-
Intervention groups
-
Treatment group will receive a 30mg zinc gloconate tablet and control group will receive a 30mg maltose-dextrin tablet.
-
Main outcome variables
-
Serum concentration of brain derived neurotrophic factor vascular endothelial growth factor, Methylglyoxal, Pentosidine, Carboxymethyl lysine, Metalloproteinase 9, Caspase 3
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT2014040617150N1
Registration date:
2014-08-02, 1393/05/11
Registration timing:
registered_while_recruiting
Last update:
2018-01-31, 1396/11/11
Update count:
1
-
Registration date
-
2014-08-02, 1393/05/11
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Vice chancellor for Research, Tabriz University of Medical Sciences
-
Expected recruitment start date
-
2014-07-23, 1393/05/01
-
Expected recruitment end date
-
2015-01-21, 1393/11/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Placebo-controlled clinical trial to determine the effects of dietary zinc supplementation on serum levels of brain-derived neurotrophic factor, vascular endothelial growth factor, advanced glycation end products, metalloproteinas 9 and caspase 3 in patients with diabetic retinopathy
-
Public title
-
Effect of zinc supplementation in the treatment of diabetic retinopathy
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Age range 40-70 years old
suffering from type 2 diabetes without insulin
Subject diagnosed with diabetic retinopathy
Exclusion criteria:
Insulin injection
Having chronic diseases such as cardiovascular disorders, renal and hepatic
Having malabsorption syndrome and inflammatory bowel disease.
Pregnancy and lactation
Drugs interfering with zinc (Penicillin amine, Diethylenetriamine pentaacetate)
; Inhibitor drugs vascular endothelial growth factor (Avastin)
Receiving nutritional supplements from 2 months before the study (zinc, calcium, vitamin A and iron)
Exercise on a regular basis
Having a mental illness such as depression
Infectious diseases and AIDS
Alcoholism
-
Age
-
From 40 years old to 70 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
-
Sample size
-
Target sample size:
50
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Using random block method (blocks with a volume of at least 4 to prevent the blinding of the study), using RAS software
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
The participants and the main researcher are blinded and using randomly blocked with a minimum volume of 4 to prevent the blindness of the study.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2014-07-17, 1393/04/26
-
Ethics committee reference number
-
9359
Health conditions studied
1
-
Description of health condition studied
-
Diabetic retinopathy
-
ICD-10 code
-
H36.0
-
ICD-10 code description
-
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
-
Description
-
serum concentration of zinc
-
Timepoint
-
At baseline and after 3 months of intervention
-
Method of measurement
-
atomic absorption spectrophotometry
2
-
Description
-
serum concentration of brain derived neurotrophic factor
-
Timepoint
-
At baseline and after 3 months of intervention
-
Method of measurement
-
ELISA
3
-
Description
-
serum concentration of vascular endothelial growth factor
-
Timepoint
-
At baseline and after 3 months of intervention
-
Method of measurement
-
ELISA
4
-
Description
-
serum concentration of Methylglyoxal
-
Timepoint
-
At baseline and after 3 months of intervention
-
Method of measurement
-
ELISA
5
-
Description
-
serum concentration Pentosidine
-
Timepoint
-
At baseline and after 3 months of intervention
-
Method of measurement
-
ELISA
6
-
Description
-
serum concentration Carboxymethyl lysine
-
Timepoint
-
At baseline and after 3 months of intervention
-
Method of measurement
-
ELISA
7
-
Description
-
serum concentration Metalloproteinase 9
-
Timepoint
-
At baseline and after 3 months of intervention
-
Method of measurement
-
ELISA
8
-
Description
-
serum concentration Caspase 3
-
Timepoint
-
At baseline and after 3 months of intervention
-
Method of measurement
-
ELISA
Secondary outcomes
1
-
Description
-
serum concentration of Insulin
-
Timepoint
-
At baseline and after 8 weeks of intervention
-
Method of measurement
-
Chemiluminescence
2
-
Description
-
Fasting blood sugar
-
Timepoint
-
At baseline and after 8 weeks of intervention
-
Method of measurement
-
Enzymatic colorimetric method
3
-
Description
-
serum concentration of HbA1c
-
Timepoint
-
At baseline and after 8 weeks of intervention
-
Method of measurement
-
Turbidimetry
4
-
Description
-
Insulin Resistance Index
-
Timepoint
-
At baseline and after 8 weeks of intervention
-
Method of measurement
-
Based on the formula of Insulin Resistance Index
5
-
Description
-
Systolic blood pressure
-
Timepoint
-
At baseline and after 8 weeks of intervention
-
Method of measurement
-
Stethoscope and sphygmomanometer
6
-
Description
-
Diastolic blood pressure
-
Timepoint
-
At baseline and after 8 weeks of intervention
-
Method of measurement
-
Stethoscope and sphygmomanometer
Intervention groups
1
-
Description
-
The case group will receive a 30mg zinc gloconate tablet for 3 months, one to two hours after lunch. The tablets will provided by jalinous pharmaceutical company in Tehran . All the patients will receive the supplements on a weekly base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews.
-
Category
-
Treatment - Drugs
2
-
Description
-
The control group will receive a 30mg maltose- dextrin tablet as placebo for 3 months, one to two hours after lunch. The tablets will be provided by the Faculty of Pharmacy, Tabriz University of Medical Sciences.All the patients will receive the placebo on a weekly base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews.
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Vice chancellor for Research, Tabriz 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
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
-
Not applicable
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Not applicable
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable