The current study is a double-blind clinical trial in which 84 patients with type 2 diabetes and hypertension are selected as a sample in Diabetes Research Center of University. According to randomized permuted block method, they are randomly divided into tow groups namely, intervention and control. Vitamin C supplement with a dose of 250 mg and the placebo are given to intervention and control group respectively, each of one 4 times a day during 6 weeks.Their blood pressure are recorded at the biginning and the end of study. People who are under treatment regimen or have kidney stone will be excluded from the study. In the end of the study,the blood pressure of two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014093019342N1
Registration date:2014-10-22, 1393/07/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-10-22, 1393/07/30
Registrant information
Name
Zainab Shateri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
Email address
zshateri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
The cost of this research are supplied by Tehran University of Medical Sciences.
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin C supplementation on blood pressure levels in patients with type 2 diabetes
Public title
Effect of vitamin C on blood pressure control in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with diabetes and hypertension; overweight; more than 30 years of age and under 60 years of age; not smoking and alcohol; non kidney stones; non use of oral contraceptives pills in women; fasting blood sugar of 126 to 250.
Exclusion criteria: changes in medications; non-use of prescribed supplements; Unwillingness to engage in continuing study; the use of a specific treatment regimen
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Central Organization of Tehran University of Medical Sciences, corner of Qods Street, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2014-10-04, 1393/07/12
Ethics committee reference number
125918
Health conditions studied
1
Description of health condition studied
Hypertension in diabetes
ICD-10 code
I15
ICD-10 code description
secondary hypertension
Primary outcomes
1
Description
blood pressure
Timepoint
on the first intervention and on the forty-second day
Method of measurement
Mercury Sphygmomanometer
Secondary outcomes
1
Description
fasting blood sugar
Timepoint
At the beginning and the end of study
Method of measurement
Method of Glucose Oxidase
Intervention groups
1
Description
Intervention group: chewable vitamin C supplement at a dose of 250 mg 4 times a day during 6 weeks
Category
Treatment - Drugs
2
Description
Control group: chewable placebo of vitamin C 4 times a day for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Research Center of Tehran University of Medical Sciences
Full name of responsible person
Zainab Shateri
Street address
Diabetes and Metabolic Diseases Clinic, Heyat corner, West Shahrivar Street, below the Heart Center, North Kargar Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Haniye Rostamabadi
Street address
Central Organization of Tehran University of Medical Sciences, corner of Qods Street, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Keshavarz
Position
PhD in Nutrition Sciences / Master
Other areas of specialty/work
Street address
Faculty of Nutrition Sciences and Dietetics, No.44, Hojjatdoudt Street, Naderi Street, Keshavarz Blvd
City
Tehran
Postal code
1997763551
Phone
+98 21 8895 5897
Fax
+98 21 8895 5897
Email
s_akeshavarz@yahoo.com
Web page address
tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nutrition Sciences and Dietetics
Full name of responsible person
Dr.Seyed Ali Keshavarz
Position
PhD in Nutrition Sciences
Other areas of specialty/work
Street address
Faculty of Nutrition Sciences and Dietetics, No.44, Hojjatdoudt Street, Naderi Street, Keshavarz Blvd
City
Tehran
Postal code
1997763551
Phone
+98 21 8895 5897
Fax
+98 21 8895 5897
Email
s_akeshavarz@yahoo.com
Web page address
tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nutrition Sciences and Dietetics
Full name of responsible person
Zainab Shateri
Position
MSc student in Nutrition Sciences
Other areas of specialty/work
Street address
Faculty of Nutrition Sciences and Dietetics, No.44, Hojjatdoudt Street, Naderi Street, Keshavarz Blvd
City
Tehran
Postal code
1997763551
Phone
+98 21 8895 5897
Fax
+98 21 8895 5897
Email
zainabshateri@gmail.com**zshateri@razi.tums.ac.ir
Web page address
tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)