Vitamin C Supplementation Plus Hypoglycemic Agents Versus Hypoglycemic Agents Alone in Type 2 Diabetes Mellitus (Vit C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Hamdan Zaki Hamdan, Al-Neelain University

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.

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C
U.S. FDA Resources

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.
Dietary Supplement: Vitamin C
Vitamin C supplementation 500mg
Active Comparator: Type 2DM patients receiving oral hypoglycemic agents alone
this group is the control group who receive oral hypoglycemic agents alone
Drug: glyburide
this group receiving glyburide 5 mg alone

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01319734

Contact: Hamdan Z Hamdan, MBBS, Msc +249912468264
Contact: Maha I Mohammed, MBBS, PhD +249912230895

Jaber abo aliz Recruiting
Khartoum, Sudan, 1111
Contact: Khaled H Bakheet, MD,PhD    +249912957764   
Principal Investigator: Hamdan Z Hamdan, MBBS,MSc         
Sponsors and Collaborators
Al-Neelain University
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 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
Ascorbic Acid
Hypoglycemic Agents
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents