The Influence of Lutein Supplements on Age-related Macular Degeneration
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 4
- Primary Endpoint
- Macular Pigment Optical Density
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •AMD grade 2 or 3
- •visual acuity > 0.5
- •BMI < 30
Exclusion Criteria
- •using lutein supplements
- •diseases that interfere with lipid absorption
- •other eye diseases
Outcomes
Primary Outcomes
Macular Pigment Optical Density
Time Frame: Baseline, 4 months, 8 months, 12 months
Secondary Outcomes
- Visual Acuity(Baseline, 4 months, 8 months, 12 months)