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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by Hamdan Zaki Hamdan, Al-Neelain University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Hamdan Zaki Hamdan, Al-Neelain University Identifier:
First received: March 21, 2011
Last updated: September 17, 2013
Last verified: September 2013

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 Intervention Phase
Type 2 Diabetes Mellitus Dietary Supplement: Vitamin C Drug: glyburide Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Hamdan Zaki Hamdan, Al-Neelain University:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 50
Study Start Date: February 2011
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: March 21, 2011
Last Updated: September 17, 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 processed this record on September 21, 2017