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

Phase 4UnknownNCT01921192

University of Catania160 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

160

Conditions

Non Proliferative Diabetic Retinopathy Proliferative Diabetic Retinopathy

Interventions

Folic Acid, vit B6 and B12DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * diabetic patients with proliferative and non proliferative retinopathy Exclusion Criteria: * Patients with chronic liver disease Patients with kidney disease.

Locations (1)

University of Catania, Cannizzaro Hospital

Catania, Italy

RECRUITING

Outcomes

Primary Outcomes

homocysteine

Time frame: 12 months

Secondary Outcomes

folic acid

Time frame: 12 months

Central Contacts

Mariano Malaguarnera, A.P.

CONTACT

+39(0)957262008 malaguar@unict.it

Data from ClinicalTrials.gov

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