Back to resultsLong Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA) (LUTEGA)
Primary Purpose
Age Related Maculopathy
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Lutein/ Zeaxanthin + Omega-3-FA
Lutein/ Zeaxanthin + Omega-3-FA
Placebo
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
Sites / Locations
- Department of Ophthalmology, University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
Arm Description
20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year
10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year
Placebo
Outcomes
Primary Outcome Measures
Optical density of macular pigment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00763659
Brief Title
Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)
Acronym
LUTEGA
Official Title
Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (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 is it to determine the long term effect (about 1 year) of the supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids on the optical density (OD) of macular pigment in patients with non- exudative age related maculopathy.
Furthermore, it is to be examined whether changes of the optical density are different dosages dependent. Possible changes of lipofuscin content and effect on drusen in AMD patients are studied. The measurement of optical density of macular pigment uses the 1- wavelength reflection method recording reflection images at 460 nm by a fundus camera. The patients are investigated at baseline and are followed up over one year in four more visits. In addition to the OD- measurement each examination includes standardized visual acuity test (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and autofluorescence) and a blood sample.
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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year
Arm Title
2
Arm Type
Active Comparator
Arm Description
10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Lutein/ Zeaxanthin + Omega-3-FA
Intervention Description
20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year
Intervention Type
Dietary Supplement
Intervention Name(s)
Lutein/ Zeaxanthin + Omega-3-FA
Intervention Description
10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
0 mg Lutein, Zeaxanthin, Omega-3-FA
Primary Outcome Measure Information:
Title
Optical density of macular pigment
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All non- exudative forms of age related maculopathy
Exclusion Criteria:
Exudative age related maculopathy
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 Hospital, Jena
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, University Hospital
City
Jena
ZIP/Postal Code
07743
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
23695657
Citation
Dawczynski J, Jentsch S, Schweitzer D, Hammer M, Lang GE, Strobel J. Long term effects of lutein, zeaxanthin and omega-3-LCPUFAs supplementation on optical density of macular pigment in AMD patients: the LUTEGA study. Graefes Arch Clin Exp Ophthalmol. 2013 Dec;251(12):2711-23. doi: 10.1007/s00417-013-2376-6. Epub 2013 May 22.
Results Reference
derived
PubMed Identifier
23519529
Citation
Arnold C, Winter L, Frohlich K, Jentsch S, Dawczynski J, Jahreis G, Bohm V. Macular xanthophylls and omega-3 long-chain polyunsaturated fatty acids in age-related macular degeneration: a randomized trial. JAMA Ophthalmol. 2013 May;131(5):564-72. doi: 10.1001/jamaophthalmol.2013.2851.
Results Reference
derived
Learn more about this trial
Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)
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