Back to resultsLong Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation for Two More Years (LUTEGA 2)
Primary Purpose
Age Related Maculopathy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lutein/ Zeaxanthin + Omega- 3- Fatty Acids
Sponsored by
About this trial
This is an interventional prevention trial for Age Related Maculopathy
Eligibility Criteria
Inclusion Criteria:
- All non- exudative forms of age related maculopathy
Exclusion Criteria:
- Exudative age related maculopathy
- decrease opacity of ocular media
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
D2x - D1x
D1x - D2x
D1x - D1x
Arm Description
Cross Over from double dosage to single dosage: daily supplementation with 10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FAabout two years after one year with 20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA
Cross Over from double dosage to single dosage: daily supplementation with 20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA about two years after one year with 10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA
single dosage: daily supplementation about two years after one year with 10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA (dosage remains existing)
Outcomes
Primary Outcome Measures
Optical density of macular pigment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01648660
Brief Title
Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation for Two More Years (LUTEGA 2)
Official Title
Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients for Two More Years (LUTEGA 2)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jena
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of LUTEGA 2 is it to determine the long term effect (about 2 more years after LUTEGA 1, NCT00763659) of the supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids in two different dosages on the optical density (OD) of macular pigment in patients with non- exudative age related maculopathy. The dosage groups are crossed after LUTEGA 1.
Detailed Description
The LUTEGA 2 is a cross-over- study and the continue of LUTEGA 1. After one year of supplementation in randomized, placebo- controlled, double blind study (LUTEGA 1), the treatment arms are unblind to cross over the different dosage groups.
The measurement of optical density of macular pigment (MPOD) uses the 1- wavelength reflection method recording reflection images at 480 nm by a fundus camera. The patients are followed up over two years in eight more visits (every three months) In addition to the MPOD- measurement each examination includes standardized visual acuity test (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and autofluorescence) and a blood sample (every six months).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Maculopathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D2x - D1x
Arm Type
Active Comparator
Arm Description
Cross Over from double dosage to single dosage:
daily supplementation with 10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FAabout two years after one year with 20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA
Arm Title
D1x - D2x
Arm Type
Active Comparator
Arm Description
Cross Over from double dosage to single dosage:
daily supplementation with 20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA about two years after one year with 10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA
Arm Title
D1x - D1x
Arm Type
Active Comparator
Arm Description
single dosage: daily supplementation about two years after one year with 10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA (dosage remains existing)
Intervention Type
Dietary Supplement
Intervention Name(s)
Lutein/ Zeaxanthin + Omega- 3- Fatty Acids
Intervention Description
capsule with Lutein, Zeaxanthin, Omega-3-FA for two years
Primary Outcome Measure Information:
Title
Optical density of macular pigment
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All non- exudative forms of age related maculopathy
Exclusion Criteria:
Exudative age related maculopathy
decrease opacity of ocular media
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürgen Strobel, MD
Organizational Affiliation
University Hospital Jena
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jens Dawczynski, MD
Organizational Affiliation
University of Leipzig
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation for Two More Years (LUTEGA 2)
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