NCT00763659

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: University of Jena · Academic / Other
• Sex: All
• Age: 50 Years – 95 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2008-05-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2008-10-01
• Last updated: 2012-07-20

Locations

1 site across 1 country: Germany