Effect of selenium supplementation and vitamin C on Hemoglobin A1c in type 2 diabetic patients
Design
The clinical trial included control group with parallel group, One blind, Randomized by the random numbers of the participants.
Settings and conduct
Determine the effect of selenium supplementation and vitamin C on Hemoglobin A1c in type 2 diabetic patients in Bushehr in 2017.Sampling in the laboratory of the Khalij hospital in Bushehr, One blind spot ( participants) with Simulation of supplementation and placebo, randomized.
Participants/Inclusion and exclusion criteria
Inclusion Criteria : Patients with diabetes type 2, patients with age between 25 to 65 years.
Exclusion Criteria: Patients with diabetes type 1, patients with age less than 25 or more than 65, patients with kidney stone.
Intervention groups
The effect of selenium supplementation and vitamin C on four random groups include:
1.Recipient Group with selenium and vitamin C
2.Recipient Group with selenium
3.Recipient Group with vitamin C
4.Recipient Group with placebo
Main outcome variables
Determine the Serum levels of Hemoglobin A1c in patients with diabet type 2; Determine the effect of selenium on Hemoglobin A1c in patients with diabet type 2; Determine the effect of vitamin C on Hemoglobin A1c in patients with diabetes type 2.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160514027879N3
Registration date:2018-10-06, 1397/07/14
Registration timing:registered_while_recruiting
Last update:2018-10-06, 1397/07/14
Update count:0
Registration date
2018-10-06, 1397/07/14
Registrant information
Name
Abbas Yousefinejad
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 3345 0178
Email address
a.yousefinezhad@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-27, 1397/04/06
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Selenium and vitamin C supplementation on Hba1c levels in patients with diabetes type 2
Public title
Effect of Selenium and vitamin C supplementation on Hba1c levels in patients with diabetes type 2
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
patients with diabetes type 2 and between 25 to 65 years old
Exclusion criteria:
patients with diabetes type 1, pregnancy , patients with kidney stone
Age
From 25 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization , individual Randomization , base on the random numbers of participants .
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants, Simulation of supplementation and placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Bushehr University of Medical Sciences
Street address
Bushehr University of Medical Scinces, Moallem St, Kuy-e-Bandar, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
7518759577
Approval date
2018-01-15, 1396/10/25
Ethics committee reference number
IR.BPUMS.REC.1396.152
Health conditions studied
1
Description of health condition studied
Diabetes type 2
ICD-10 code
E11.28
ICD-10 code description
Type 2 diabetes mellitus with unspecified complications
Primary outcomes
1
Description
Hemoglobin A1c
Timepoint
7 days before intervention and 3 months after intervention
Method of measurement
Specific Kit for measuring the Hba1c levels
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Selenium Receiving Group
Category
Treatment - Drugs
2
Description
Intervention group: Vitamin C Receiving Group
Category
Treatment - Drugs
3
Description
Intervention group: Selenium and Vitamin C Receiving Group
Category
Treatment - Drugs
4
Description
Control group: Placebo Receiving Group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
The Shohadaye Khalije Fars Hospital of Bushehr province
Full name of responsible person
Abbas Yousefinejad
Street address
Shahid Taleghani Boulevard. Bushehr
City
Bushehr
Province
Boushehr
Postal code
7517933755
Phone
+98 77 3345 5375
Email
MPGH@BPUMS.AC.IR
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholamreza Khamisipour
Street address
Busheur university of medical sciences, Salman Farsi Street, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0178
Email
Research@bpums.ac.ir
Grant name
80000000 Rial
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Abbas Yousefinejad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Moallem St, Bushehr Province, Bandar Bushehr, Kuy-e-Bandar
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
a.yousefinezhad@bpums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Abbas Yousefinezhad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Moallem street, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
a.yousefinezhad@bpums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Abbas Yousefinezhad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Moallem street, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
a.yousefinezhad@bpums.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
Information about the changes of principle massage
When the data will become available and for how long
beginning of the access period from 2019
To whom data/document is available
for all researches,Professors and students .
Under which criteria data/document could be used
according to the ethical instructions and obey Copy Right
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document