Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation for Two More Years (LUTEGA 2)
NCT ID: NCT01648660
Last Updated: 2013-01-10
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
80 participants
INTERVENTIONAL
2009-05-31
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)
NCT00763659
Effects of Lutein Supplementation on Macular Pigment Optical Density and Visual Acuity in Patients With Age-related Macular Degeneration
NCT00879671
Lutein/Zeaxanthin and Omega-3 Supplementation in Persons Over Age 60
NCT00121589
Effects of Lutein and Zeaxanthin Supplementation on Age-related Macular Degeneration
NCT01048476
Lutein for Age-Related Macular Degeneration
NCT00006202
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
D2x - D1x
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
Lutein/ Zeaxanthin + Omega- 3- Fatty Acids
capsule with Lutein, Zeaxanthin, Omega-3-FA for two years
D1x - D2x
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
Lutein/ Zeaxanthin + Omega- 3- Fatty Acids
capsule with Lutein, Zeaxanthin, Omega-3-FA for two years
D1x - D1x
single dosage: daily supplementation about two years after one year with 10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA (dosage remains existing)
Lutein/ Zeaxanthin + Omega- 3- Fatty Acids
capsule with Lutein, Zeaxanthin, Omega-3-FA for two years
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lutein/ Zeaxanthin + Omega- 3- Fatty Acids
capsule with Lutein, Zeaxanthin, Omega-3-FA for two years
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* decrease opacity of ocular media
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Jena
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jens Dawczynski
Prof. Dr. med. Jens Dawczynski
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jürgen Strobel, MD
Role: STUDY_DIRECTOR
University Hospital Jena
Jens Dawczynski, MD
Role: PRINCIPAL_INVESTIGATOR
University of Leipzig
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2032- 06/07
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.