NCT00563979

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®.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

2.4 years

First QC Date

November 26, 2007

Last Update Submit

June 10, 2015

Conditions

Age-Related Maculopathies

Keywords

age related macular degenerationsupplementationmacular pigment

Outcome Measures

Primary Outcomes (1)

  • Macular pigment density

    6 months

Secondary Outcomes (1)

  • contrast sensitivity

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

VitaluxPlus®

Dietary Supplement: VitaluxPlus®

2

ACTIVE COMPARATOR

Omega 3

Dietary Supplement: Omega 3

Interventions

VitaluxPlus®DIETARY_SUPPLEMENT

1 tablet daily

1
Omega 3DIETARY_SUPPLEMENT

1 tablet daily

2

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age related maculopathy

You may not qualify if:

  • exudative age related degeneration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik und Poliklinik für Augenheilkunde, University Bern

Bern, Switzerland

Location

Related Publications (2)

  • Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.

    PMID: 37702300DERIVED

  • Wolf-Schnurrbusch UE, Zinkernagel MS, Munk MR, Ebneter A, Wolf S. Oral Lutein Supplementation Enhances Macular Pigment Density and Contrast Sensitivity but Not in Combination With Polyunsaturated Fatty Acids. Invest Ophthalmol Vis Sci. 2015 Dec;56(13):8069-74. doi: 10.1167/iovs.15-17586.

    PMID: 26720458DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Sebastian Wolf, MD

    University of Bern

    STUDY DIRECTOR

  • Ute Wolf-Schnurrbusch, MD

    University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 26, 2007

First Posted

November 27, 2007

Study Start

July 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 12, 2015

Record last verified: 2015-06

Locations

CH(1)