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

January 9, 2013 updated by: Jens Dawczynski, University of Jena

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

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 and older (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
  • decrease opacity of ocular media

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Optical density of macular pigment
Time Frame: 24 months
24 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 of Leipzig

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, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 19, 2012

First Submitted That Met QC Criteria

July 19, 2012

First Posted (Estimate)

July 24, 2012

Study Record Updates

Last Update Posted (Estimate)

January 10, 2013

Last Update Submitted That Met QC Criteria

January 9, 2013

Last Verified

January 1, 2013

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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