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

July 19, 2012 updated by: Jens Dawczynski, University of Jena

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Jena, Germany, 07743
        • Department of Ophthalmology, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All non- exudative forms of age related maculopathy

Exclusion Criteria:

  • Exudative age related maculopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3
Placebo
Dietary supplement: Placebo
0 mg Lutein, Zeaxanthin, Omega-3-FA
Active Comparator: 1
20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year
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
Active Comparator: 2
10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Optical density of macular pigment
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jena

Investigators

  • Study Director: Jürgen Strobel, MD, University Hospital, Jena
  • Principal Investigator: Jens Dawczynski, MD, University Hospital, Jena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

September 30, 2008

First Posted (Estimate)

October 1, 2008

Study Record Updates

Last Update Posted (Estimate)

July 20, 2012

Last Update Submitted That Met QC Criteria

July 19, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2032-06/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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