Effect of Folic Acid, Vitamin B6 and Vitamin B12 in Diabetic Retinopathy

August 8, 2013 updated by: Mariano Malaguarnera, University of Catania
Homocysteine, a well-known inducer of vascular endothelial cell damage has been associated with extracellular matrix changes. Many studies demonstrated that high levels of this aminoacid in diabetic patients increases significantly the risk of the development of this pathology. This study has been undertaken to investigate the role of homocysteine and its cofactors (folic acid, vitamin B6 and B12) during the progression of the diabetic retinopathy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 4

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

  • Name: Mariano Malaguarnera, A.P.
  • Phone Number: +39(0)957262008
  • Email: malaguar@unict.it

Study Locations

  • Italy
      • Catania, Italy, 95125
        • Recruiting
        • University of Catania, Cannizzaro Hospital

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

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diabetic patients with proliferative and non proliferative retinopathy

Exclusion Criteria:

  • Patients with chronic liver disease Patients with kidney 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Sugar pill
Drug: Placebo
Active Comparator: Folic Acid, vit B6 and B12
Drug: Folic Acid, vit B6 and B12

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
homocysteine
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
folic acid
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Time Frame
vitamin B6
Time Frame: 12 months
12 months
vitamin B12
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

University of Catania

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

September 1, 2012

Primary Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

August 8, 2013

First Posted (Estimate)

August 13, 2013

Study Record Updates

Last Update Posted (Estimate)

August 13, 2013

Last Update Submitted That Met QC Criteria

August 8, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/2012

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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