A clinical trial to compare the effectiveness of vitamin C with placebo on fast blood sugar and hemoglobin A1C levels on type 2 diabetes patient
Design
54 patients whose type 2 diabetes and visited at diabetes Clinic of Imam Reza Hospital were chosen randomly and assigned to control and intervention groups. A code was allocated to each of the participants.
Settings and conduct
Patients with type 2 diabetes visiting at diabetes clinic of Department of Imam Reza Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with type 2 diabetes who receive only oral diabetes treatment that have not changed their treatment for last three months; Having HbA1c less than 8.
Exclusion criteria: Having kidney stones, GFR less than 60, having gestational diabetes, insulin-treated patients; pregnant women.
Intervention groups
The intervention group are revising 4 tablets of 250 mg of vitamin C (Producing by Iranian pharmaceutical company) per day for 3 months. The control group are revising 4 tablets of 250 mg of placebo (Having same color of vitamin C tablets without any active ingredient) per day for 3 months.
Main outcome variables
Evaluation and comparison of the amount of fast blood sugar (FBS), hemoglobin A1C (HbA1C), Cholesterol, triglyceride (TG), HDL and LDL levels by laboratory experiment in the intervention and control groups before, and 3 months after intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180627040253N1
Registration date:2018-07-02, 1397/04/11
Registration timing:prospective
Last update:2018-07-02, 1397/04/11
Update count:0
Registration date
2018-07-02, 1397/04/11
Registrant information
Name
Behzad Razavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3854 3031
Email address
razavib@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-02, 1397/07/10
Expected recruitment end date
2019-10-02, 1398/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of vitamin C with placebo on fast blood sugar and hemoglobin A1C levels on type 2 diabetes patient.
Public title
The effect of vitamin C on type 2 diabetes patient.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes who receive only oral diabetes treatment that have not changed their treatment for last three months
Having HbA1c less than 8
Exclusion criteria:
Having kidney stones, , , ,
GFR less than 60
Having gestational diabetes
Insulin-treated patients
pregnant women
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
54 patients whose type 2 diabetes and visited at diabetes Clinic of Imam Reza Hospital were chosen randomly based on random numbers table is compiled by computers that regulate the numbers randomly, and assigned to control and intervention groups. A code was allocated to each of the participants.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients with type 2 diabetes and visited at diabetes Clinic of Department of Imam Reza Hospital, are chosen as the participants of the study. In this double-blind study, the participants and responsible for data collection are unaware of type of drug.
Placebo
Used
Assignment
Parallel
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
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2018-04-30, 1397/02/10
Ethics committee reference number
IR.mums.fm.rec 1397.160
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
the amount of fast blood sugar (FBS), hemoglobin A1C (HbA1C), Cholesterol, triglyceride (TG), HDL and LDL levels
Timepoint
before, and 3 months after intervention
Method of measurement
Laboratory experiment
Secondary outcomes
empty
Intervention groups
1
Description
Control group: who are revising 4 tablets of 250 mg of placebo (Having same color of vitamin C tablets without any active ingredient) per day for 3 months. Fast blood sugar (FBS), hemoglobin A1C (HbA1C), Cholesterol, triglyceride (TG), HDL and LDL levels will be measured by laboratory experiment before, and 3 months after intervention.
Category
Treatment - Drugs
2
Description
Intervention group: who are revising 4 tablets of 250 mg of vitamin C (Producing by Iranian pharmaceutical company) per day for 3 months. Fast blood sugar (FBS), hemoglobin A1C (HbA1C), Cholesterol, triglyceride (TG), HDL and LDL levels will be measured by laboratory experiment before, and 3 months after intervention.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Behzad Razavi
Street address
Imam Reza Hospital, Ibn Sina Avenue, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2000
Email
emamreza@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
913750345
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
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
Behzad Razavi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Reza Hospital, Ibn Sina Avenue, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2000
Email
razavib@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Behzad Razavi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Reza Hospital, Ibn Sina Avenue, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2000
Email
razavib@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Behzad Razavi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Reza Hospital, Ibn Sina Avenue, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2000
Email
razavib@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Behzad Razavi provides the analysis code to the applicants via email: razavib@mums.ac.ir
What processes are involved for a request to access data/document
Data collection was done for 10 months, data were collected one month, statistical analysis of one month, information dissemination as a article six months.