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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jens Dawczynski, University of Leipzig
ClinicalTrials.gov Identifier:
NCT01648660
First received: July 19, 2012
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Jena:

Primary Outcome Measures:
  • Optical density of macular pigment [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: May 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648660

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

No publications provided

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
Study First Received: July 19, 2012
Last Updated: January 9, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013