The Influence of Lutein Supplements on Age-related Macular Degeneration
1 other identifier
interventional
80
2 countries
2
Brief Summary
Rationale: Age-related macular degeneration is the most common cause of blindness in the industrialized world. Macular pigment is hypothesized to protect against the vision loss in this disease. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2007
Typical duration for not_applicable
2 active sites
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
Study Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 5, 2010
CompletedFirst Posted
Study publicly available on registry
January 6, 2010
CompletedJanuary 8, 2010
January 1, 2010
2 years
January 5, 2010
January 7, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Macular Pigment Optical Density
Baseline, 4 months, 8 months, 12 months
Secondary Outcomes (1)
Visual Acuity
Baseline, 4 months, 8 months, 12 months
Study Arms (2)
supplement
ACTIVE COMPARATORlutein supplement
placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- AMD grade 2 or 3
- visual acuity \> 0.5
- BMI \< 30
You may not qualify if:
- using lutein supplements
- smoking
- diabetes
- diseases that interfere with lipid absorption
- other eye diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Eye Clinic Maastricht
Maastricht, 6202 AZ, Netherlands
Faculty of Life Sciences, University of Manchester
Manchester, M60 1QD, United Kingdom
Related Publications (1)
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.
PMID: 23385792DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tos TJM Berendschot, PhD
University Eye Clinic Maastricht
- PRINCIPAL INVESTIGATOR
Ian J Murray, PhD
University of Manchester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 5, 2010
First Posted
January 6, 2010
Study Start
August 1, 2007
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
January 8, 2010
Record last verified: 2010-01