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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 25, 2014