We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01921192
Recruitment Status : Unknown
Verified August 2013 by Mariano Malaguarnera, University of Catania.
Recruitment status was:  Recruiting
First Posted : August 13, 2013
Last Update Posted : August 13, 2013
Sponsor:
Information provided by (Responsible Party):

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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2012
Estimated Primary Completion Date : July 2014


Arms and Interventions

Arm Intervention/treatment
Active Comparator: Folic Acid, vit B6 and B12 Drug: Folic Acid, vit B6 and B12
Placebo Comparator: Sugar pill Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. homocysteine [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. folic acid [ Time Frame: 12 months ]

Other Outcome Measures:
  1. vitamin B6 [ Time Frame: 12 months ]
  2. vitamin B12 [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diabetic patients with proliferative and non proliferative retinopathy

Exclusion Criteria:

  • Patients with chronic liver disease Patients with kidney disease.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921192


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

Locations
Italy
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
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Folic Acid
Vitamin B Complex
Pyridoxine
Vitamin B 6
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs