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

University of Jena

Status: Completed

Conditions: Age Related Maculopathy

Treatments: Dietary Supplement: Lutein/ Zeaxanthin + Omega- 3- Fatty Acids

Study type: Interventional

Funder types: Other

Identifiers

NCT01648660

2032- 06/07

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All non- exudative forms of age related maculopathy

Exclusion criteria

• Exudative age related maculopathy
• decrease opacity of ocular media

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

D2x - D1x

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Lutein/ Zeaxanthin + Omega- 3- Fatty Acids

D1x - D2x

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Lutein/ Zeaxanthin + Omega- 3- Fatty Acids

D1x - D1x

Active Comparator group

Description:

single dosage: daily supplementation about two years after one year with 10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA (dosage remains existing)

Treatment:

Dietary Supplement: Lutein/ Zeaxanthin + Omega- 3- Fatty Acids