Evaluation of a New Eye-specific Multivitamin Formula in Participants at Risk of Age-related Macular Degeneration (AMD)
NCT ID: NCT03946085
Last Updated: 2019-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
79 participants
INTERVENTIONAL
2018-01-19
2018-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Lumega-Z group
Participants assigned the study supplement Lumega-Z.
Lumega-Z
A specially-formulated carotenoid supplement formula that utilizes a micronized, lipid-based liquid form of delivery.
AREDS2 group
Participants assigned the AREDS2 supplement
AREDS2
A commercially-available multivitamin soft gel formula.
Control
Participants are determined ocular normal after clinical examination and do not have retinal drusen.
No interventions assigned to this group
Interventions
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Lumega-Z
A specially-formulated carotenoid supplement formula that utilizes a micronized, lipid-based liquid form of delivery.
AREDS2
A commercially-available multivitamin soft gel formula.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* prior history of retinal-detachment or vitreo-retinal surgeries with any complications
* best-corrected visual acuity of 20/40 or worse
18 Years
ALL
Yes
Sponsors
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Western University of Health Sciences
OTHER
Eye Clinic of Austin
OTHER
Guardion Health Sciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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T Henderson
Role: PRINCIPAL_INVESTIGATOR
Eye Clinic of Austin
Locations
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Eye Clinic of Austin
Austin, Texas, United States
Countries
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References
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Davey PG, Henderson T, Lem DW, Weis R, Amonoo-Monney S, Evans DW. Visual Function and Macular Carotenoid Changes in Eyes with Retinal Drusen-An Open Label Randomized Controlled Trial to Compare a Micronized Lipid-Based Carotenoid Liquid Supplementation and AREDS-2 Formula. Nutrients. 2020 Oct 26;12(11):3271. doi: 10.3390/nu12113271.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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Protocol Number 2
Identifier Type: -
Identifier Source: org_study_id
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