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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sebastian Wolf, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00563979
First received: November 26, 2007
Last updated: October 26, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Age-Related Maculopathies
Dietary Supplement: VitaluxPlus®
Dietary Supplement: Omega 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Enhancement of Macular Pigment Density by Oral Lutein Supplementation

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Macular pigment density, contrast sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: July 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
VitaluxPlus®
Dietary Supplement: VitaluxPlus®
1 tablet daily
Active Comparator: 2 Dietary Supplement: Omega 3
1 tablet daily

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age related maculopathy

Exclusion Criteria:

  • exudative age related degeneration
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Sebastian Wolf, Director, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00563979     History of Changes
Other Study ID Numbers: KEK 152/07
Study First Received: November 26, 2007
Last Updated: October 26, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
AMD
supplementation
macular pigment

ClinicalTrials.gov processed this record on October 21, 2014