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

NCT ID: NCT01319734

Last Updated: 2013-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Keywords

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Vitamin C Oxidative stress Type 2DM

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Vitamin C

Intervention Type DIETARY_SUPPLEMENT

Vitamin C supplementation 500mg

Type 2DM patients receiving oral hypoglycemic agents alone

this group is the control group who receive oral hypoglycemic agents alone

Group Type ACTIVE_COMPARATOR

glyburide

Intervention Type DRUG

this group receiving glyburide 5 mg alone

Interventions

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Vitamin C

Vitamin C supplementation 500mg

Intervention Type DIETARY_SUPPLEMENT

glyburide

this group receiving glyburide 5 mg alone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Neelain University

OTHER

Sponsor Role lead

Responsible Party

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Hamdan Zaki Hamdan

Al-Neelain University, Faculty of Medicine, Department of Biochemistry and Molecular biology, Khartoum, Sudan

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hamdan Z Hamdan, MBBS, MSc

Role: PRINCIPAL_INVESTIGATOR

Al-Neelain University

Locations

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Jaber abo aliz

Khartoum, Khartoum State, Sudan

Site Status RECRUITING

Countries

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Sudan

Central Contacts

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Hamdan Z Hamdan, MBBS, Msc

Role: CONTACT

Phone: +249912468264

Email: [email protected]

Maha I Mohammed, MBBS, PhD

Role: CONTACT

Phone: +249912230895

Facility Contacts

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Khaled H Bakheet, MD,PhD

Role: primary

Other Identifiers

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22

Identifier Type: -

Identifier Source: org_study_id