Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)
NCT ID: NCT00763659
Last Updated: 2012-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
172 participants
INTERVENTIONAL
2008-05-31
2011-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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1
20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year
Lutein/ Zeaxanthin + Omega-3-FA
20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year
2
10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year
Lutein/ Zeaxanthin + Omega-3-FA
10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year
3
Placebo
Placebo
0 mg Lutein, Zeaxanthin, Omega-3-FA
Interventions
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Lutein/ Zeaxanthin + Omega-3-FA
20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year
Lutein/ Zeaxanthin + Omega-3-FA
10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year
Placebo
0 mg Lutein, Zeaxanthin, Omega-3-FA
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
50 Years
95 Years
ALL
No
Sponsors
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University of Jena
OTHER
Responsible Party
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Jens Dawczynski
Prof. Dr. med. jens Dawczynski
Principal Investigators
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Jürgen Strobel, MD
Role: STUDY_DIRECTOR
University Hospital, Jena
Jens Dawczynski, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Jena
Locations
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Department of Ophthalmology, University Hospital
Jena, , Germany
Countries
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References
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Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.
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.
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.
Other Identifiers
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2032-06/07
Identifier Type: -
Identifier Source: org_study_id