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

Sponsored by:	University of Jena
Information provided by:	University of Jena
ClinicalTrials.gov Identifier:	NCT00763659

Purpose

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.

Condition	Intervention
Age Related Maculopathy	Dietary Supplement: Lutein/ Zeaxanthin + Omega-3-FA Dietary Supplement: Placebo

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Dietary Supplements Diets Macular Degeneration

Drug Information available for: Lutein Zeaxanthin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Official Title:	Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)

Further study details as provided by University of Jena:

Primary Outcome Measures:

Optical density of macular pigment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	May 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	50 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All non- exudative forms of age related maculopathy

Exclusion Criteria:

Exudative age related maculopathy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763659

Contacts

Contact: Jens Dawczynski, MD

Jens.Dawczynski@med.uni-jena.de

Locations

Germany
Department of Ophthalmology, University Hospital	Recruiting
Jena, Germany, 07743
Contact: Jens Dawczynski, MD Jens.Dawczynski@med.uni-jena.de
Principal Investigator: Jens Dawczynski, MD

Sponsors and Collaborators

University of Jena

Investigators

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

More Information

No publications provided

Responsible Party:	Department of Ophthalmology, University Hospital Jena ( Prof. Jürgen Strobel )
Study ID Numbers:	2032-06/07
Study First Received:	September 30, 2008
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00763659 History of Changes
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases

Additional relevant MeSH terms:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on May 07, 2009