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

September 17, 2013 updated by: Hamdan Zaki Hamdan, Al-Neelain University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Maha I Mohammed, MBBS, PhD
  • Phone Number: +249912230895

Study Locations

  • Sudan
      • Khartoum, Sudan, 1111
        • Recruiting
        • Jaber abo aliz
        • Contact:
        • Principal Investigator:
          • Hamdan Z Hamdan, MBBS,MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
the renal function will be measure at day 1 and after one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
the visual field will be assesed at day 1 and after one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Neelain University

Investigators

  • Principal Investigator: Hamdan Z Hamdan, MBBS, MSc, Al-Neelain University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

March 21, 2011

First Submitted That Met QC Criteria

March 21, 2011

First Posted (ESTIMATE)

March 22, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 18, 2013

Last Update Submitted That Met QC Criteria

September 17, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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