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

NCT ID: NCT01921192

Last Updated: 2013-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Brief Summary

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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

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Conditions

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Non Proliferative Diabetic Retinopathy Proliferative Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Folic Acid, vit B6 and B12

Group Type ACTIVE_COMPARATOR

Folic Acid, vit B6 and B12

Intervention Type DRUG

Sugar pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Folic Acid, vit B6 and B12

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* diabetic patients with proliferative and non proliferative retinopathy

Exclusion Criteria

* Patients with chronic liver disease Patients with kidney disease.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Catania

OTHER

Sponsor Role lead

Responsible Party

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Mariano Malaguarnera

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Catania, Cannizzaro Hospital

Catania, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Mariano Malaguarnera, A.P.

Role: CONTACT

Phone: +39(0)957262008

Email: [email protected]

Other Identifiers

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1/2012

Identifier Type: -

Identifier Source: org_study_id