The Influence of Lutein Supplements on Age-related Macular Degeneration

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Age-Related Macular Degeneration

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Lutein

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01042860

061052

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

supplement

Active Comparator group

Description:

lutein supplement

Treatment:

Dietary Supplement: Lutein

placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo