Enhancement of Macular Pigment Density by Oral Lutein Supplementation

Age-Related Maculopathies Clinical Trial

— EMPOLS  

Official title:

Enhancement of Macular Pigment Density by Oral Lutein Supplementation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00563979
• Other study ID #: KEK 152/07
• Status: Completed
• Phase: N/A
• First received: November 26, 2007
• Last updated: June 10, 2015
• Start date: July 2007
• Est. completion date: December 2009

Study information

• Verified date: June 2015
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The primary objective of EMPOLS is an increase in macular pigment density (MPD) and contrast sensitivity (CS) after six months supplementation of oral non-compound ester Lutein 10 mg daily, contained in VitaluxPlus®.

Description:

The primary objective of EMPOLS is an increase in macular pigment density (MPD) and contrast sensitivity (CS) after six months supplementation of oral non-compound ester Lutein 10 mg daily, contained in VitaluxPlus®. Primary variable for a significant change will be 10% increase compared to baseline MPD.

The measurement will be carried out by means of a modified confocal scanning laser ophthalmoscope (HRA) recording autofluorescence images at 488 nm and 514 nm 6. MPD is determined on MPD maps within 0.5 degrees around the center of the fovea. All MPD measurements and photographs will by performed by the Bern Photographic Reading Center (BPRC). Complete examination of study patients comprises testing of standardized visual acuity (ETDRS-VA), visual contrast sensitivity (CS), biomicroscopy, fundus photography, and a blood sample. Participating patients also have to fill out a food frequency questionnaire (FFQ-Bern) allowing for correction of additional lutein intake by regular diet. Moreover possible confounding factors e.g. as sunlight exposure or smoking habits will be assessed. Secondary objective of EMPOLS is the effect of oral non-compound ester lutein supplementation on CS and ETDRS-VA during one year. The variable for a significant change in ETDRS-VA is loss or gain of 7 letters on the ETDRS chart, for a change in CS: loss or gain of at least four letters on the Pelli-Robson CS Chart. Additionally, serum carotenoid levels of lutein will be determined by high performance liquid chromatography (HPLC) for each visit 1.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• age related maculopathy

Exclusion Criteria:

• exudative age related degeneration

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Age-Related Maculopathies

Intervention

Dietary Supplement:
• VitaluxPlus®
1 tablet daily
• Omega 3
1 tablet daily

Locations

Country	Name	City	State
Switzerland	Klinik und Poliklinik für Augenheilkunde, University Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular pigment density		6 months	No
Secondary	contrast sensitivity		6 months	No