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 because the information has not been verified recently.
Verified September 2013 by Al-Neelain University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Al-Neelain University
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
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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 (Adult, Senior) |
| 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
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
| 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:
|
Hypoglycemic Agents Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vitamins Ascorbic Acid |
Glyburide Micronutrients Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on September 23, 2016