The Influence of Lutein Supplements on Age-related Macular Degeneration
NCT ID: NCT01042860
Last Updated: 2010-01-08
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
80 participants
INTERVENTIONAL
2007-08-31
2009-08-31
Brief Summary
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Objective: 1. To study if the macular pigment optical density can be raised by lutein supplementation. 2. To study if lutein supplementation can stop or slow down the decrease in visual functions.
Study design: Randomized, double blind, placebo controlled intervention study.
Study population: Eighty patients with early signs of age-related macular degeneration Intervention: The intervention group (40 subjects) receives 10 mg lutein per day, while the control group (40 subjects) gets a placebo.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
TRIPLE
Study Groups
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supplement
lutein supplement
Lutein
Lutein supplement, 10 mg daily
placebo
Placebo
Placebo
Placebo
Interventions
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Lutein
Lutein supplement, 10 mg daily
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* visual acuity \> 0.5
* BMI \< 30
Exclusion Criteria
* smoking
* diabetes
* diseases that interfere with lipid absorption
* other eye diseases
50 Years
80 Years
ALL
No
Sponsors
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Cognis Deutschland GmbH & Co. KG
INDUSTRY
Maastricht University Medical Center
OTHER
Responsible Party
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Cognis Deutschland GmbH & Co. KG
Principal Investigators
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Tos TJM Berendschot, PhD
Role: PRINCIPAL_INVESTIGATOR
University Eye Clinic Maastricht
Ian J Murray, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Manchester
Locations
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University Eye Clinic Maastricht
Maastricht, , Netherlands
Faculty of Life Sciences, University of Manchester
Manchester, , United Kingdom
Countries
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References
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Murray IJ, Makridaki M, van der Veen RL, Carden D, Parry NR, Berendschot TT. Lutein supplementation over a one-year period in early AMD might have a mild beneficial effect on visual acuity: the CLEAR study. Invest Ophthalmol Vis Sci. 2013 Mar 11;54(3):1781-8. doi: 10.1167/iovs.12-10715.
Other Identifiers
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061052
Identifier Type: -
Identifier Source: org_study_id
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