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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Arms and Interventions

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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

Outcome Measures

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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.

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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