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NCT01921192 Clinical Trial

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

Proliferative Diabetic Retinopathy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01921192
Other study ID # 1/2012
Secondary ID
Status Recruiting
Phase Phase 4
First received August 8, 2013
Last updated August 8, 2013
Start date September 2012

Study information
Verified date August 2013
Source University of Catania
Contact Mariano Malaguarnera, A.P.
Phone +39(0)957262008
Email malaguar@unict.it
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 160
Est. completion date
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria:

- diabetic patients with proliferative and non proliferative retinopathy

Exclusion Criteria:

- Patients with chronic liver disease Patients with kidney disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Folic Acid, vit B6 and B12

• Placebo

Locations
Country Name City State
Italy University of Catania, Cannizzaro Hospital Catania

Sponsors (1)
Lead Sponsor Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Other vitamin B6 12 months Yes
Other vitamin B12 12 months Yes
Primary homocysteine 12 months Yes
Secondary folic acid 12 months Yes
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