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

NCT00763659 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2012-07-20

No results posted yet for this study

Summary

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.

Conditions

  • Age Related Maculopathy

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

Sponsors & Collaborators

  • University of Jena

    lead OTHER

Principal Investigators

  • Jürgen Strobel, MD · University Hospital, Jena

  • Jens Dawczynski, MD · University Hospital, Jena

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00763659 on ClinicalTrials.gov