- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01042860
The Influence of Lutein Supplements on Age-related Macular Degeneration
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Maastricht, Netherlands, 6202 AZ
- University Eye Clinic Maastricht
-
-
-
-
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Manchester, United Kingdom, M60 1QD
- Faculty of Life Sciences, University of Manchester
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- AMD grade 2 or 3
- visual acuity > 0.5
- BMI < 30
Exclusion Criteria:
- using lutein supplements
- smoking
- diabetes
- diseases that interfere with lipid absorption
- other eye diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
Placebo
|
Placebo
|
Active Comparator: supplement
lutein supplement
|
Lutein supplement, 10 mg daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Macular Pigment Optical Density
Time Frame: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual Acuity
Time Frame: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ian J Murray, PhD, University of Manchester
- Principal Investigator: Tos TJM Berendschot, PhD, University Eye Clinic Maastricht
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 061052
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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