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Enhancement of Macular Pigment Density by Oral Lutein Supplementation (EMPOLS)

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ClinicalTrials.gov Identifier: NCT00563979
Recruitment Status : Completed
First Posted : November 27, 2007
Last Update Posted : June 12, 2015
Sponsor:
Information provided by (Responsible Party):
Sebastian Wolf, University Hospital Inselspital, Berne

Brief 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®.

Condition or disease Intervention/treatment Phase
Age-Related Maculopathies Dietary Supplement: VitaluxPlus® Dietary Supplement: Omega 3 Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Enhancement of Macular Pigment Density by Oral Lutein Supplementation
Study Start Date : July 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
VitaluxPlus®
Dietary Supplement: VitaluxPlus®
1 tablet daily
Active Comparator: 2
Omega 3
Dietary Supplement: Omega 3
1 tablet daily



Primary Outcome Measures :
  1. Macular pigment density [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. contrast sensitivity [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age related maculopathy

Exclusion Criteria:

  • exudative age related degeneration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00563979


Locations
Switzerland
Klinik und Poliklinik für Augenheilkunde, University Bern
Bern, Switzerland
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Study Director: Sebastian Wolf, MD University of Bern
Principal Investigator: Ute Wolf-Schnurrbusch, MD University of Bern

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sebastian Wolf, Director, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00563979     History of Changes
Other Study ID Numbers: KEK 152/07
First Posted: November 27, 2007    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015

Keywords provided by Sebastian Wolf, University Hospital Inselspital, Berne:
age related macular degeneration
supplementation
macular pigment