Vitamin C Supplementation Plus Hypoglycemic Agents Versus Hypoglycemic Agents Alone in Type 2 Diabetes Mellitus
Vit C
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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 21, 2011
CompletedFirst Posted
Study publicly available on registry
March 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedSeptember 18, 2013
September 1, 2013
4.8 years
March 21, 2011
September 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Vitamin C can improve the visual fields
the visual field will be assesed at day 1 and after one month
Study Arms (2)
Vitamin C supplementation plus oral hypoglycemic agents arm
EXPERIMENTALThis group will receive vitamin C supplementation 500mg daily for one month and then assessment will done for the patients.
Type 2DM patients receiving oral hypoglycemic agents alone
ACTIVE COMPARATORthis group is the control group who receive oral hypoglycemic agents alone
Interventions
Eligibility Criteria
You may qualify if:
- clinical diagnosis of type 2DM
- patients in good health
- receiving oral hypoglycemic drugs
You may not qualify if:
- Insulin dependent diabetes
- receiving vitamin complex
- smoking
- renal disease
- liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jaber abo aliz
Khartoum, Khartoum State, 1111, Sudan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hamdan Z Hamdan, MBBS, MSc
Al-Neelain University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Al-Neelain University, Faculty of Medicine, Department of Biochemistry and Molecular biology, Khartoum, Sudan
Study Record Dates
First Submitted
March 21, 2011
First Posted
March 22, 2011
Study Start
February 1, 2011
Primary Completion
December 1, 2015
Last Updated
September 18, 2013
Record last verified: 2013-09