Investigation of Macular Pigment Augmentation on Dark Adaptation

Tracking Information
First Submitted Date ICMJE	May 22, 2007
First Posted Date ICMJE	May 24, 2007
Last Update Posted Date	October 27, 2010
Study Start Date ICMJE	December 2007
Actual Primary Completion Date	September 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 22, 2007)	Dark Adaptation [ Time Frame: Measured 3 times over 8 months ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00478439 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 22, 2007)	Macular Pigment Density [ Time Frame: Measured 3 times over 8 months ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Investigation of Macular Pigment Augmentation on Dark Adaptation
Official Title ICMJE	Investigation of Macular Pigment Augmentation on Dark Adaptation
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.
Detailed Description	The study design is a randomized, double-blinded, placebo-controlled intervention study that will evaluate whether macular pigment augmentation improves the speed of dark adaptation. Two groups of participants will be enrolled, old adults with normal vision and early age-related macular degeneration patients. Macular pigment will be augmented using EyePromise RESTORE (ZeaVision, Inc). EyePromise RESTORE is a nutritional supplement that has been found to increase macular pigment levels in some users. Macular pigment level and the speed of dark adaptation (how fast a person adjusts to the dark) will be assessed at baseline, 4-months, and 8-months. Fundus appearance will be assessed at baseline and 8-months follow-up.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator)
Condition ICMJE	Aging; Age-Related Macular Degeneration
Intervention ICMJE	Dietary Supplement: ZeaVision EyePromise Restore Vitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, Zeaxanthin 8mg,mixed tocopherols 6mg, lutein 4mg,; Dietary Supplement: Multivitamin Vitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, mixed tocopherols 6mg, lutein 4mg,
Study Arms	Placebo Comparator: Placebo Comparator; Interventions: Dietary Supplement: ZeaVision EyePromise Restore; Dietary Supplement: Multivitamin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: October 26, 2010)	13
Original Estimated Enrollment ICMJE; (submitted: May 22, 2007)	40
Actual Study Completion Date	October 2010
Actual Primary Completion Date	September 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 60 to 80 years old; < +- 4.00 diopters spherical equivalent; normal eye health or early age-related macular degeneration Exclusion Criteria: neurological conditions that can impair vision; diabetes
Sex/Gender	Sexes Eligible for Study: All
Ages	60 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00478439
Other Study ID Numbers ICMJE	F070410002
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Leo P. Semes, O.D./Principal Investigator, UAB School of Optometry
Study Sponsor ICMJE	University of Alabama at Birmingham
Collaborators ICMJE	ZeaVision, Inc.
Investigators ICMJE	Principal Investigator: Leo P Semes, O.D. University of Alabama at Birmingham
PRS Account	University of Alabama at Birmingham
Verification Date	October 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP