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Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation for Two More Years (LUTEGA 2)

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ClinicalTrials.gov Identifier: NCT01648660
Recruitment Status : Completed
First Posted : July 24, 2012
Last Update Posted : January 10, 2013
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Age Related Maculopathy Dietary Supplement: Lutein/ Zeaxanthin + Omega- 3- Fatty Acids

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).


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : May 2009
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 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

Dietary Supplement: Lutein/ Zeaxanthin + Omega- 3- Fatty Acids
capsule with Lutein, Zeaxanthin, Omega-3-FA for two years
Active Comparator: 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

Dietary Supplement: Lutein/ Zeaxanthin + Omega- 3- Fatty Acids
capsule with Lutein, Zeaxanthin, Omega-3-FA for two years
Active Comparator: 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)
Dietary Supplement: Lutein/ Zeaxanthin + Omega- 3- Fatty Acids
capsule with Lutein, Zeaxanthin, Omega-3-FA for two years


Outcome Measures

Primary Outcome Measures :
  1. Optical density of macular pigment [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All non- exudative forms of age related maculopathy

Exclusion Criteria:

  • Exudative age related maculopathy
  • decrease opacity of ocular media
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648660


Sponsors and Collaborators
University of Jena
Investigators
Study Director: Jürgen Strobel, MD University Hospital Jena
Principal Investigator: Jens Dawczynski, MD University of Leipzig
More Information

Responsible Party: Jens Dawczynski, Prof. Dr. med. Jens Dawczynski, University of Leipzig
ClinicalTrials.gov Identifier: NCT01648660     History of Changes
Other Study ID Numbers: 2032- 06/07
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013