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

Phase 4

• Conditions: Non Proliferative Diabetic Retinopathy; Proliferative Diabetic Retinopathy
• Interventions: Drug: Placebo; Drug: Folic Acid, vit B6 and B12

• Registration Number: NCT01921192
• Lead Sponsor: University of Catania

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Status Verified: 2013-08
• Study First Submitted: 2013-08-08
• Study First Submitted QC: 2013-08-08
• Last Update Submitted: 2013-08-08
• Study First Posted: 2013-08-13
• Last Update Posted: 2013-08-13
• Primary Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• diabetic patients with proliferative and non proliferative retinopathy

Exclusion Criteria

• Patients with chronic liver disease Patients with kidney disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar pill	Placebo	-
Folic Acid, vit B6 and B12	Folic Acid, vit B6 and B12	-

Primary Outcome Measures

Name	Time	Method
homocysteine	12 months

Secondary Outcome Measures

Name	Time	Method
folic acid	12 months

Trial Locations

Locations (1)

University of Catania, Cannizzaro Hospital; 🇮🇹 Catania, Italy