Back to resultsEffect of Folic Acid, Vitamin B6 and Vitamin B12 in Diabetic Retinopathy
Primary Purpose
Non Proliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Folic Acid, vit B6 and B12
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non Proliferative Diabetic Retinopathy
Eligibility Criteria
Inclusion Criteria:
- diabetic patients with proliferative and non proliferative retinopathy
Exclusion Criteria:
- Patients with chronic liver disease Patients with kidney disease.
Sites / Locations
- University of Catania, Cannizzaro HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Folic Acid, vit B6 and B12
Sugar pill
Arm Description
Outcomes
Primary Outcome Measures
homocysteine
Secondary Outcome Measures
folic acid
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01921192
Brief Title
Effect of Folic Acid, Vitamin B6 and Vitamin B12 in Diabetic Retinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Proliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Folic Acid, vit B6 and B12
Arm Type
Active Comparator
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Folic Acid, vit B6 and B12
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
homocysteine
Time Frame
12 months
Secondary Outcome Measure Information:
Title
folic acid
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
vitamin B6
Time Frame
12 months
Title
vitamin B12
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
diabetic patients with proliferative and non proliferative retinopathy
Exclusion Criteria:
Patients with chronic liver disease Patients with kidney disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariano Malaguarnera, A.P.
Phone
+39(0)957262008
Email
malaguar@unict.it
Facility Information:
Facility Name
University of Catania, Cannizzaro Hospital
City
Catania
ZIP/Postal Code
95125
Country
Italy
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Effect of Folic Acid, Vitamin B6 and Vitamin B12 in Diabetic Retinopathy
We'll reach out to this number within 24 hrs