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

Not Applicable

Completed

• Conditions: Age Related Maculopathy
• Interventions: Dietary Supplement: Lutein/ Zeaxanthin + Omega- 3- Fatty Acids

• Registration Number: NCT01648660
• Lead Sponsor: University of Jena

Brief Summary

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.

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 Timeline

• Study Start: 2009-05
• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-24
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-09
• Last Update Posted: 2013-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• All non- exudative forms of age related maculopathy

Exclusion Criteria

• Exudative age related maculopathy
• decrease opacity of ocular media

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
D2x - D1x	Lutein/ Zeaxanthin + Omega- 3- Fatty Acids	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
D1x - D2x	Lutein/ Zeaxanthin + Omega- 3- Fatty Acids	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
D1x - D1x	Lutein/ Zeaxanthin + Omega- 3- Fatty Acids	single dosage: daily supplementation about two years after one year with 10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA (dosage remains existing)

Primary Outcome Measures

Name	Time	Method
Optical density of macular pigment	24 months