Back to resultsVitamin C Supplementation Plus Hypoglycemic Agents Versus Hypoglycemic Agents Alone in Type 2 Diabetes Mellitus (Vit C)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Phase 1
Locations
Sudan
Study Type
Interventional
Intervention
Vitamin C
glyburide
Sponsored by
About this trial
This is an interventional supportive care trial for Type 2 Diabetes Mellitus focused on measuring Vitamin C, Oxidative stress, Type 2DM
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis of type 2DM
- patients in good health
- receiving oral hypoglycemic drugs
Exclusion Criteria:
- Insulin dependent diabetes
- receiving vitamin complex
- smoking
- renal disease
- liver disease
Sites / Locations
- Jaber abo alizRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vitamin C supplementation plus oral hypoglycemic agents arm
Type 2DM patients receiving oral hypoglycemic agents alone
Arm Description
This group will receive vitamin C supplementation 500mg daily for one month and then assessment will done for the patients.
this group is the control group who receive oral hypoglycemic agents alone
Outcomes
Primary Outcome Measures
improving the renal function
vitamin c supplementation act as an antioxidants which reduce the oxidative stress and then can improve the renal function.
Secondary Outcome Measures
Vitamin C can improve the visual fields
the damage of the eye can be prevented by decreasing the oxidative stress in the eye, this can be accomplished by vitamin C.
Full Information
NCT ID
NCT01319734
First Posted
March 21, 2011
Last Updated
September 17, 2013
Sponsor
Al-Neelain University
1. Study Identification
Unique Protocol Identification Number
NCT01319734
Brief Title
Vitamin C Supplementation Plus Hypoglycemic Agents Versus Hypoglycemic Agents Alone in Type 2 Diabetes Mellitus
Acronym
Vit C
Official Title
Phase 1 Study of Randomized Clinical Trial Comparing Vitamin C Supplementation Plus Oral Hypoglycemic Drugs Versus Hypoglycemic Drugs Alone on Serum Selenium, Zinc, Copper and Malondialdehyde Levels in Type 2 Diabetes Mellitus and Its Microvascular Complications
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Neelain University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Null hypothesis:
No significant effect of vitamin C 500 mg Supplementation on the severity of micro-vascular complications of type 2 Diabetes Mellitus (DM).
Alternative hypothesis:
There is a significant effect of vitamin C 500mg supplementation on the severity of the micro-vascular complications of type 2DM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Vitamin C, Oxidative stress, Type 2DM
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin C supplementation plus oral hypoglycemic agents arm
Arm Type
Experimental
Arm Description
This group will receive vitamin C supplementation 500mg daily for one month and then assessment will done for the patients.
Arm Title
Type 2DM patients receiving oral hypoglycemic agents alone
Arm Type
Active Comparator
Arm Description
this group is the control group who receive oral hypoglycemic agents alone
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C
Intervention Description
Vitamin C supplementation 500mg
Intervention Type
Drug
Intervention Name(s)
glyburide
Intervention Description
this group receiving glyburide 5 mg alone
Primary Outcome Measure Information:
Title
improving the renal function
Description
vitamin c supplementation act as an antioxidants which reduce the oxidative stress and then can improve the renal function.
Time Frame
the renal function will be measure at day 1 and after one month
Secondary Outcome Measure Information:
Title
Vitamin C can improve the visual fields
Description
the damage of the eye can be prevented by decreasing the oxidative stress in the eye, this can be accomplished by vitamin C.
Time Frame
the visual field will be assesed at day 1 and after one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of type 2DM
patients in good health
receiving oral hypoglycemic drugs
Exclusion Criteria:
Insulin dependent diabetes
receiving vitamin complex
smoking
renal disease
liver disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamdan Z Hamdan, MBBS, Msc
Phone
+249912468264
Email
hamdanology@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maha I Mohammed, MBBS, PhD
Phone
+249912230895
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamdan Z Hamdan, MBBS, MSc
Organizational Affiliation
Al-Neelain University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jaber abo aliz
City
Khartoum
ZIP/Postal Code
1111
Country
Sudan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khaled H Bakheet, MD,PhD
Phone
+249912957764
Email
khalid2_3456@yahoo.com
First Name & Middle Initial & Last Name & Degree
Hamdan Z Hamdan, MBBS,MSc
12. IPD Sharing Statement
Learn more about this trial
Vitamin C Supplementation Plus Hypoglycemic Agents Versus Hypoglycemic Agents Alone in Type 2 Diabetes Mellitus
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