Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation for Two More Years (LUTEGA 2)
1 other identifier
interventional
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2009
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 19, 2012
CompletedFirst Posted
Study publicly available on registry
July 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJanuary 10, 2013
January 1, 2013
3.6 years
July 19, 2012
January 9, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Optical density of macular pigment
24 months
Study Arms (3)
D2x - D1x
ACTIVE COMPARATORCross 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
D1x - D2x
ACTIVE COMPARATORCross 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
D1x - D1x
ACTIVE COMPARATORsingle dosage: daily supplementation about two years after one year with 10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA (dosage remains existing)
Interventions
capsule with Lutein, Zeaxanthin, Omega-3-FA for two years
Eligibility Criteria
You may qualify if:
- All non- exudative forms of age related maculopathy
You may not qualify if:
- Exudative age related maculopathy
- decrease opacity of ocular media
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jürgen Strobel, MD
University Hospital Jena
- PRINCIPAL INVESTIGATOR
Jens Dawczynski, MD
University of Leipzig
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med. Jens Dawczynski
Study Record Dates
First Submitted
July 19, 2012
First Posted
July 24, 2012
Study Start
May 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
January 10, 2013
Record last verified: 2013-01