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

Overview

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.

Full Title of Study: “Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients for Two More Years (LUTEGA 2)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2012

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).

Interventions

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

Arms, Groups and Cohorts

  • 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
  • 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
  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • Optical density of macular pigment
    • Time Frame: 24 months

Participating in This Clinical Trial

Inclusion Criteria

  • All non- exudative forms of age related maculopathy

Exclusion Criteria

  • Exudative age related maculopathy
  • decrease opacity of ocular media

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Jena
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jens Dawczynski, Prof. Dr. med. Jens Dawczynski – University of Leipzig
  • Overall Official(s)
    • J├╝rgen Strobel, MD, Study Director, University Hospital Jena
    • Jens Dawczynski, MD, Principal Investigator, University of Leipzig

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