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

U

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

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

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

Trial contacts and locations

1

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Central trial contact

Mariano Malaguarnera, A.P.

Data sourced from clinicaltrials.gov

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