NCT01921192

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Last Updated

August 13, 2013

Status Verified

August 1, 2013

Enrollment Period

1.8 years

First QC Date

August 8, 2013

Last Update Submit

August 8, 2013

Conditions

Non Proliferative Diabetic RetinopathyProliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • homocysteine

    12 months

Secondary Outcomes (1)

  • folic acid

    12 months

Other Outcomes (2)

  • vitamin B6

    12 months

  • vitamin B12

    12 months

Study Arms (2)

Folic Acid, vit B6 and B12

ACTIVE COMPARATOR
Drug: Folic Acid, vit B6 and B12

Sugar pill

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Folic Acid, vit B6 and B12DRUG
Folic Acid, vit B6 and B12
PlaceboDRUG
Sugar pill

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diabetic patients with proliferative and non proliferative retinopathy

You may not qualify if:

  • Patients with chronic liver disease Patients with kidney disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Catania, Cannizzaro Hospital

Catania, 95125, Italy

RECRUITING

MeSH Terms

Interventions

Folic AcidVitamin B 6Vitamin B 12

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPicolinesPyridinesHeterocyclic Compounds, 1-RingCorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 4 or More RingsMacrocyclic CompoundsPolycyclic Compounds

Central Study Contacts

Mariano Malaguarnera, A.P.

CONTACT

+39(0)957262008malaguar@unict.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 8, 2013

First Posted

August 13, 2013

Study Start

September 1, 2012

Primary Completion

July 1, 2014

Last Updated

August 13, 2013

Record last verified: 2013-08

Locations

IT(1)