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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Al-Neelain University
Sponsor:
Information provided by (Responsible Party):
Hamdan Zaki Hamdan, Al-Neelain University
ClinicalTrials.gov Identifier:
NCT01319734
First received: March 21, 2011
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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: 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 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01319734

Contacts
Contact: Hamdan Z Hamdan, MBBS, Msc +249912468264 hamdanology@hotmail.com
Contact: Maha I Mohammed, MBBS, PhD +249912230895

Locations
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         
Sponsors and Collaborators
Al-Neelain University
Investigators
Principal Investigator: Hamdan Z Hamdan, MBBS, MSc Al-Neelain University
  More Information

No publications provided

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
Study First Received: March 21, 2011
Last Updated: September 17, 2013
Health Authority: Sudan: Al-Neelain University Research Center

Keywords provided by Al-Neelain University:
Vitamin C
Oxidative stress
Type 2DM

Additional relevant MeSH terms:
Ascorbic Acid
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glyburide
Hypoglycemic Agents
Vitamins
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 27, 2014