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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):
Mariano Malaguarnera, University of Catania

Tracking Information
First Submitted Date  ICMJE August 8, 2013
First Posted Date  ICMJE August 13, 2013
Last Update Posted Date August 13, 2013
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
homocysteine [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
folic acid [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 8, 2013)
  • vitamin B6 [ Time Frame: 12 months ]
  • vitamin B12 [ Time Frame: 12 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Folic Acid, Vitamin B6 and Vitamin B12 in Diabetic Retinopathy
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Non Proliferative Diabetic Retinopathy
  • Proliferative Diabetic Retinopathy
Intervention  ICMJE
  • Drug: Folic Acid, vit B6 and B12
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Folic Acid, vit B6 and B12
    Intervention: Drug: Folic Acid, vit B6 and B12
  • Placebo Comparator: Sugar pill
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 8, 2013)
160
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diabetic patients with proliferative and non proliferative retinopathy

Exclusion Criteria:

  • Patients with chronic liver disease Patients with kidney disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01921192
Other Study ID Numbers  ICMJE 1/2012
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mariano Malaguarnera, University of Catania
Study Sponsor  ICMJE University of Catania
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Catania
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP