Effect of Folic Acid, Vitamin B6 and Vitamin B12 in Diabe... | NCT01921192

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

NCT01921192

Sponsor

University of Catania

Status

Unknown status

Last Update Posted

Aug 13, 2013Estimated

Enrollment

160Estimated

Phase

Phase 4

Conditions

Non Proliferative Diabetic Retinopathy
Proliferative Diabetic Retinopathy

Interventions

Folic Acid, vit B6 and B12
Placebo

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Jul 2014Estimated

Completion Date

Not provided

First Submitted Date

Aug 8, 2013

First Submission Date that Met QC Criteria

Aug 8, 2013

First Posted Date

Aug 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2013

Last Update Posted Date

Aug 13, 2013Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Folic Acid, vit B6 and B12	Active Comparator		Drug: Folic Acid, vit B6 and B12
Sugar pill	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Folic Acid, vit B6 and B12	Drug		Folic Acid, vit B6 and B12
Placebo

Measure	Description	Time Frame
homocysteine		12 months

Measure	Description	Time Frame
folic acid		12 months

Measure	Description	Time Frame
vitamin B6		12 months
vitamin B12		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diabetic patients with proliferative and non proliferative retinopathy

Exclusion Criteria:

Patients with chronic liver disease Patients with kidney disease.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mariano Malaguarnera, A.P.	Contact	+39(0)957262008		malaguar@unict.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Catania, Cannizzaro Hospital	Recruiting	Catania		95125	Italy

Intervention Browse Module

MeSH Terms

ID	Term
D005492	Folic Acid
D025101	Vitamin B 6
D014805	Vitamin B 12

Ancestor Terms

ID	Term
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided