Vitamin C Supplementation Plus Hypoglycemic Agents Versus Hypoglycemic Agents Alone in Type 2 Diabetes Mellitus (Vit C)
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ClinicalTrials.gov Identifier: NCT01319734 |
Recruitment Status
: Unknown
Verified September 2013 by Hamdan Zaki Hamdan, Al-Neelain University.
Recruitment status was: Recruiting
First Posted
: March 22, 2011
Last Update Posted
: September 18, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus | Dietary Supplement: Vitamin C Drug: glyburide | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
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 Start Date : | February 2011 |
Estimated Primary Completion Date : | December 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Vitamin C supplementation plus oral hypoglycemic agents arm
This group will receive vitamin C supplementation 500mg daily for one month and then assessment will done for the patients.
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Dietary Supplement: Vitamin C
Vitamin C supplementation 500mg
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Active Comparator: Type 2DM patients receiving oral hypoglycemic agents alone
this group is the control group who receive oral hypoglycemic agents alone
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Drug: glyburide
this group receiving glyburide 5 mg alone
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- improving the renal function [ Time Frame: the renal function will be measure at day 1 and after one month ]vitamin c supplementation act as an antioxidants which reduce the oxidative stress and then can improve the renal function.
- Vitamin C can improve the visual fields [ Time Frame: the visual field will be assesed at day 1 and after one month ]the damage of the eye can be prevented by decreasing the oxidative stress in the eye, this can be accomplished by vitamin C.

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Ages Eligible for Study: | 20 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319734
Contact: Hamdan Z Hamdan, MBBS, Msc | +249912468264 | hamdanology@hotmail.com | |
Contact: Maha I Mohammed, MBBS, PhD | +249912230895 |
Sudan | |
Jaber abo aliz | Recruiting |
Khartoum, Sudan, 1111 | |
Contact: Khaled H Bakheet, MD,PhD +249912957764 khalid2_3456@yahoo.com | |
Principal Investigator: Hamdan Z Hamdan, MBBS,MSc |
Principal Investigator: | Hamdan Z Hamdan, MBBS, MSc | Al-Neelain University |
Responsible Party: | Hamdan Zaki Hamdan, Al-Neelain University, Faculty of Medicine, Department of Biochemistry and Molecular biology, Khartoum, Sudan, Al-Neelain University |
ClinicalTrials.gov Identifier: | NCT01319734 History of Changes |
Other Study ID Numbers: |
22 |
First Posted: | March 22, 2011 Key Record Dates |
Last Update Posted: | September 18, 2013 |
Last Verified: | September 2013 |
Keywords provided by Hamdan Zaki Hamdan, Al-Neelain University:
Vitamin C Oxidative stress Type 2DM |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vitamins Ascorbic Acid Hypoglycemic Agents |
Glyburide Micronutrients Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |