Protocol summary

Summary
The study aimed to determine the effect of Vitamins are C, E and D. The level of blood glucose and lipids in patients with type II diabetes is Key inclusion criteria: Patients with diabetes are not phenomena Passing at least three years of diagnosis Diabetes two of them openly, aged 25 to 60 years and Quit criteria included: Lack of developing heart disease, no disease is renal disease. The clinical trial will be conducted on 160 patients with diabetes and method of choice samples will be available for sampling. Patients were randomized into four groups (3 groups, each receiving one of Vitamins C, E and D and a control group receiving vitamin) Immediately before the experiments are useful food supplements Fast Blood Sugar, Creatinine, Blood Urea Nitorogen, Triglyceride, Low _Density Lipoprotein, High _Density Lipoprotein, Total Cholesterol, 2 Hours Post Prandial Blood Sugar and Urine Analysis all patients will be assessed. This means that patients in groups catch vitamin supplements, in addition to medications (eg, metformin) of vitamin D (50,000 IU orally, every week), E (capsules 400 mg daily), C (1000 tablets mg, 1 day) for 6 weeks received and the fourth group received medication only wants. After 6 weeks of treatment, all the above mentioned tests will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014071918532N1
Registration date: 2015-03-26, 1394/01/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-03-26, 1394/01/06
Registrant information
Name
Tayebeh Mahvar
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38270662
Email address
t.mahvar@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences and Diabetes Research Center
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral administration of vitamins C, E, D on blood glucose and lipids levels in patients with type 2 diabetes
Public title
The effect of vitamins C, E, D on blood lipids and glucose levels in patients with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: consciousness, ability to answer questions; That have not diabetic patients have complications from diabetes; almost three years Diagnosis them openly; aged 25 to 60. Exclusion criteria from the study: Unwillingness of the patient; not having kidney disease; Death.
Age
From 25 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Number 2 building, Kermanshah University of Medical Sciences, Shahid Beheshti Bulevared, Kermanshah, Iran
City
Kermanshah
Postal code
6714673139
Approval date
2014-06-06, 1393/03/16
Ethics committee reference number
23463

Health conditions studied

1

Description of health condition studied
diabetes type 2
ICD-10 code
E11.9
ICD-10 code description
Non-insulin-dependent diabetes mellitus without complications

Primary outcomes

1

Description
Fast Blood Sugar
Timepoint
after intervention- before 6 weeks intervention
Method of measurement
forms

2

Description
Creatinine
Timepoint
after intervention- before 6 weeks intervention
Method of measurement
forms

3

Description
High density lipoprotein
Timepoint
after intervention- before 6 weeks intervention
Method of measurement
forms

4

Description
Triglyceride
Timepoint
after intervention- before 6 weeks intervention
Method of measurement
forms

5

Description
Low density lipoprotein
Timepoint
after intervention- before 6 weeks intervention
Method of measurement
forms

6

Description
Total Cholesterol
Timepoint
after intervention- before 6 weeks intervention
Method of measurement
forms

7

Description
2 Hours Post Prandial Blood Sugar
Timepoint
after intervention- before 6 weeks intervention
Method of measurement
forms

8

Description
Urine Analysis
Timepoint
after intervention- before 6 weeks intervention
Method of measurement
forms

9

Description
Blood Urea Nitorogen
Timepoint
after intervention- before 6 weeks intervention
Method of measurement
forms

Secondary outcomes

1

Description
Renal failure
Timepoint
after of 6 weeks
Method of measurement
Urine Analysis, Creatinine, blood urea nitrogen

Intervention groups

1

Description
vitamin D, oral tablet 50000 unit once weekly, for 6 weeks
Category
Treatment - Drugs

2

Description
vitamin C, oral tablet 1000 mg daily I, for 6 weeks
Category
Treatment - Drugs

3

Description
controls, Without intervention
Category
N/A

4

Description
vitamin E, oral capsule 400 mg daily I, for 6 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Center for Diabetes Research، Kermanshah University of Medical Sciences
Full name of responsible person
Samaneh Rezaei
Street address
Center for Diabetes Research، Shahid Beheshti Boulevard، Kermanshah University of Medical Sciences
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Building number 2, Vice Chancellor for Research and Technology, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Center for Diabetes Research، Kermanshah University of Medical Sciences
Full name of responsible person
Samaneh Rezaei
Position
master of nursing
Other areas of specialty/work
Street address
Shahid Beheshti Street، Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
67119986396
Phone
+98 38270662
Fax
Email
samanehrezaei1366@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Tayebeh Mahvar
Position
PHD Student of Nursing
Other areas of specialty/work
Street address
Dolat Abad Street, School of Nursing and Midwifery، Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
67119986396
Phone
+91 81335490
Fax
Email
mandanamahvar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Samaneh Rezaei
Position
Master of nursing
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Street,Kermanshah
City
Kermanshah
Postal code
67119986396
Phone
+98 38270662
Fax
Email
samanehrezaei1366@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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