Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)

Overview

The primary objective of LUTEGA is it to determine the long term effect (about 1 year) of the supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids on the optical density (OD) of macular pigment in patients with non- exudative age related maculopathy.

Furthermore, it is to be examined whether changes of the optical density are different dosages dependent. Possible changes of lipofuscin content and effect on drusen in AMD patients are studied. The measurement of optical density of macular pigment uses the 1- wavelength reflection method recording reflection images at 460 nm by a fundus camera. The patients are investigated at baseline and are followed up over one year in four more visits. In addition to the OD- measurement each examination includes standardized visual acuity test (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and autofluorescence) and a blood sample.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: September 2011

Interventions

  • Dietary Supplement: Lutein/ Zeaxanthin + Omega-3-FA
    • 20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year
  • Dietary Supplement: Lutein/ Zeaxanthin + Omega-3-FA
    • 10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year
  • Dietary Supplement: Placebo
    • 0 mg Lutein, Zeaxanthin, Omega-3-FA

Arms, Groups and Cohorts

  • Active Comparator: 1
    • 20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year
  • Active Comparator: 2
    • 10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year
  • Placebo Comparator: 3
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Optical density of macular pigment
    • Time Frame: 12 months

Participating in This Clinical Trial

Inclusion Criteria

  • All non- exudative forms of age related maculopathy

Exclusion Criteria

  • Exudative age related maculopathy

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 95 Years

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 Hospital, Jena

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