The Influence of Lutein Supplements on Age-related Macular Degeneration

Not Applicable

Completed

• Conditions: Age-Related Macular Degeneration
• Interventions: Dietary Supplement: Lutein; Dietary Supplement: Placebo

• Registration Number: NCT01042860
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2010-01
• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-01-05
• Study First Posted: 2010-01-06
• Last Update Submitted: 2010-01-07
• Last Update Posted: 2010-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
supplement	Lutein	lutein supplement
placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Macular Pigment Optical Density	Baseline, 4 months, 8 months, 12 months

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	Baseline, 4 months, 8 months, 12 months

Trial Locations

Locations (2)

University Eye Clinic Maastricht; 🇳🇱 Maastricht, Netherlands

Faculty of Life Sciences, University of Manchester; 🇬🇧 Manchester, United Kingdom