The Influence of Lutein Supplements on Age-related Macular Degeneration
|ClinicalTrials.gov Identifier: NCT01042860|
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : January 8, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Age-Related Macular Degeneration||Dietary Supplement: Lutein Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Influence of Lutein Supplements on Age-related Macular Degeneration|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
Active Comparator: supplement
Dietary Supplement: Lutein
Lutein supplement, 10 mg daily
Placebo Comparator: placebo
Dietary Supplement: Placebo
- Macular Pigment Optical Density [ Time Frame: Baseline, 4 months, 8 months, 12 months ]
- Visual Acuity [ Time Frame: Baseline, 4 months, 8 months, 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042860
|University Eye Clinic Maastricht|
|Maastricht, Netherlands, 6202 AZ|
|Faculty of Life Sciences, University of Manchester|
|Manchester, United Kingdom, M60 1QD|
|Principal Investigator:||Tos TJM Berendschot, PhD||University Eye Clinic Maastricht|
|Principal Investigator:||Ian J Murray, PhD||University of Manchester|