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

Type 2 Diabetes Mellitus Clinical Trial

— Vit C  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01319734
• Other study ID #: 22
• Status: Recruiting
• Phase: Phase 1
• First received: March 21, 2011
• Last updated: September 17, 2013
• Start date: February 2011

Study information

• Verified date: September 2013
• Source: Al-Neelain University
• Contact: Hamdan Z Hamdan, MBBS, Msc
• Phone: +249912468264
• Email: hamdanology[@]hotmail.com
• Is FDA regulated: No
• Health authority: Sudan: Al-Neelain University Research Center
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Vitamin C
Vitamin C supplementation 500mg

Drug:
• glyburide
this group receiving glyburide 5 mg alone

Locations

Country	Name	City	State
Sudan	Jaber abo aliz	Khartoum

Sponsors (1)

Lead Sponsor	Collaborator
Al-Neelain University

Country where clinical trial is conducted

Sudan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improving the renal function	vitamin c supplementation act as an antioxidants which reduce the oxidative stress and then can improve the renal function.	the renal function will be measure at day 1 and after one month	Yes
Secondary	Vitamin C can improve the visual fields	the damage of the eye can be prevented by decreasing the oxidative stress in the eye, this can be accomplished by vitamin C.	the visual field will be assesed at day 1 and after one month	Yes