Determination of effect of Zinc and Selenium co-supplementations on blood glucose and inflammatory/antioxidant biomarkers in Type 2 Diabetes Mellitus patients
Design
Randomized double blind study with control group and parallel groups
Settings and conduct
This study will be held in Ghaem Hospital. Sample size is 80 and subjects will be distribute in each of 4 groups randomly. participants and investigators are blind.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Type 2 Diabetes, 18.5 < Body Mass Index < 30, 18 < Age < 60, 7 < Hemoglobin A1c < 9
Exclusion Criteria:
Haven't consumed zinc and selenium supplements in last 3 month; Diabetes complications; Autoimmune disorders; Cancer; Participate in any other studies; Pregnancy; Lactating; Smoking
Intervention groups
in this study participants will distribute in 4 groups and each group have 20 individuals.
Intervention group 1: Supplement Zinc+ Supplement Selenium
Intervention group 2: Supplement Zinc+ placebo Selenium
Intervention group 3: placebo Zinc+ supplement Selenium
Control group 4: Placebo Zinc+ Placebo Selenium
The Effect of Zinc and Selenium co-supplementations on blood glucose and inflammatory/antioxidant biomarkers in Type 2 Diabetes Mellitus patients
Public title
The effect of Zinc and Selenium co-supplementation in T2D patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 Diabetes Melitus
7< HA1c < 9
18.5 < BMI < 30
18 < Age < 65
Exclusion criteria:
Zinc and Selenium consumption in last 3 month
Diabetes complications
autoimmune disorders
cancer
participating in any other studies
pregnancy
Lactating
Smoking
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will allocate in each group by:
Block Sampling,
individual,
Stratified Randomization,
tools used: Computer Software.
Blinding (investigator's opinion)
Double blinded
Blinding description
in this study investigator and participants are blind from groups and how they are randomized
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, University campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2019-03-13, 1397/12/22
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.736
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Hemoglobin A1c
Timepoint
Before and after study
Method of measurement
Laboratory test
2
Description
FBS
Timepoint
Before and after of intervention
Method of measurement
Laboratory test
3
Description
Insulin
Timepoint
Before and after intervention
Method of measurement
Laboratory test
4
Description
Interleukin 1 beta
Timepoint
Before and after intervention
Method of measurement
Laboratory test
5
Description
Superoxide Dismutase
Timepoint
Before and after intervention
Method of measurement
Laboratory test
6
Description
Glutathione peroxidase
Timepoint
Before and after intervention
Method of measurement
Laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1: Zinc Supplement (contains 25mg zinc gluconate, Produced in Dine pharmacy Company, 1 time per day for 2 months, consume with water) and Selenium Supplement (Contains 100 mcg sodium selenite, produced in School of pharmacy's MUMS, 1 time per day for 2 months, consume with water).
Category
Treatment - Drugs
2
Description
Control group: Receive 1 Zinc Placebo tab (Produced in Dine Pharmacy company) and 1 Selenium placebo tab (Produced in school of Pharmacy at Mashhad University of Medical Sciences)
Category
Placebo
3
Description
Intervention group 2: Zinc Supplement (contains 25mg zinc gluconate, Produced in Dine pharmacy Company, 1 time per day for 2 months, consume with water) and Selenium Placebo ( Produced in School of pharmacy's MUMS, 1 time per day for 2 months, consume with water).
Category
Treatment - Drugs
4
Description
Intervention group 3: Intervention Group 1: Zinc Placebo ( Produced in Dine pharmacy Company, 1 time per day for 2 months, consume with water) and Selenium Supplement (Contains 100 mcg sodium selenite, produced in School of pharmacy's MUMS, 1 time per day for 2 months, consume with water).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital's Clinic
Full name of responsible person
Mariam Khosravi
Street address
Ghaem Hospital's Clinic, Parastar Ave, Ahmad_Abad ST
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2367
Fax
+98 51 3800 2421
Email
khosravim@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeid Eslami
Street address
Mashhad University of Medical Sciences, University campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2103
Fax
+98 51 3800 2421
Email
ESLAMIS@MUMS.AC.IR
Grant name
Priority Projects
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hamed Khedmatgozar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, medicine School, Mashhad University of Medical Sciences, Univesity campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2367
Fax
+98 51 3800 2421
Email
khedmatgozarh961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mariam Khosravi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrotion, medicine school, Mashhad University of Medical Sciences, University campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2367
Fax
+98 51 3800 2421
Email
khosravim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamed Khedmatgozar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Medicine School, Mashhad University of Medical Sciences, University campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 513802367
Email
Khedmatgozarh961@mums.ac.ir
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
Yes - There is a plan to make this available
Title and more details about the data/document
Primary outcomes will be share.
When the data will become available and for how long
Starting 6 month after publication
To whom data/document is available
Researchers
Under which criteria data/document could be used
For Metanalysis
From where data/document is obtainable
Making contact with Dr. Mariam Khosravi
What processes are involved for a request to access data/document
Making contact with Dr. Mariam Khosravi and asking for the data, if she approved, request will be send to university president, if they approved the data will send for applicant.