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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2013 by University of Catania.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Mariano Malaguarnera, University of Catania
ClinicalTrials.gov Identifier:
First received: August 8, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
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.

Condition Intervention Phase
Non Proliferative Diabetic Retinopathy
Proliferative Diabetic Retinopathy
Drug: Folic Acid, vit B6 and B12
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University of Catania:

Primary Outcome Measures:
  • homocysteine [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • folic acid [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • vitamin B6 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • vitamin B12 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: September 2012
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Folic Acid, vit B6 and B12 Drug: Folic Acid, vit B6 and B12
Placebo Comparator: Sugar pill Drug: Placebo


Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • diabetic patients with proliferative and non proliferative retinopathy

Exclusion Criteria:

  • Patients with chronic liver disease Patients with kidney disease.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01921192

Contact: Mariano Malaguarnera, A.P. +39(0)957262008 malaguar@unict.it

University of Catania, Cannizzaro Hospital Recruiting
Catania, Italy, 95125
Sponsors and Collaborators
University of Catania
  More Information

Responsible Party: Mariano Malaguarnera, Associate Professor, University of Catania
ClinicalTrials.gov Identifier: NCT01921192     History of Changes
Other Study ID Numbers: 1/2012 
Study First Received: August 8, 2013
Last Updated: August 8, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Vascular Diseases
Folic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 30, 2016