NCT00478439

Brief Summary

The study will evaluate whether taking a nutritional supplement designed to increase macular pigment in the eye can improve a person's ability to adjust to darkness. Patients will be assigned to take either a placebo or nutritional supplement for 8 months. Vision will be assessed at baseline, 4 months, and 8 months.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 27, 2010

Status Verified

October 1, 2010

Enrollment Period

1.8 years

First QC Date

May 22, 2007

Last Update Submit

October 26, 2010

Conditions

AgingAge-Related Macular Degeneration

Keywords

agingage-related macular degenerationmacular pigmentdark adaptation

Outcome Measures

Primary Outcomes (1)

  • Dark Adaptation

    Measured 3 times over 8 months

Secondary Outcomes (1)

  • Macular Pigment Density

    Measured 3 times over 8 months

Study Arms (1)

Placebo Comparator

PLACEBO COMPARATOR
Dietary Supplement: ZeaVision EyePromise RestoreDietary Supplement: Multivitamin

Interventions

ZeaVision EyePromise RestoreDIETARY_SUPPLEMENT

Vitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, Zeaxanthin 8mg,mixed tocopherols 6mg, lutein 4mg,

Placebo Comparator
MultivitaminDIETARY_SUPPLEMENT

Vitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, mixed tocopherols 6mg, lutein 4mg,

Placebo Comparator

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 80 years old
  • \< +- 4.00 diopters spherical equivalent
  • normal eye health or early age-related macular degeneration

You may not qualify if:

  • neurological conditions that can impair vision
  • diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB School of Optometry

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Geritol

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Leo P Semes, O.D.

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 22, 2007

First Posted

May 24, 2007

Study Start

December 1, 2007

Primary Completion

September 1, 2009

Study Completion

October 1, 2010

Last Updated

October 27, 2010

Record last verified: 2010-10

Locations

US(1)