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

University of Catania

Status and phase: Unknown; Phase 4

Conditions: Proliferative Diabetic Retinopathy; Non Proliferative Diabetic Retinopathy

Treatments: Drug: Placebo; Drug: Folic Acid, vit B6 and B12

Study type: Interventional

Funder types: Other

Identifiers

NCT01921192

1/2012

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• diabetic patients with proliferative and non proliferative retinopathy

Exclusion criteria

• Patients with chronic liver disease Patients with kidney disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups, including a placebo group

Folic Acid, vit B6 and B12

Active Comparator group

Treatment:

Drug: Folic Acid, vit B6 and B12

Sugar pill

Placebo Comparator group

Treatment:

Drug: Placebo