The Influence of Lutein Supplements on Age-related Macular Degeneration

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2009

Interventions

  • Dietary Supplement: Lutein
    • Lutein supplement, 10 mg daily
  • Dietary Supplement: Placebo
    • Placebo

Arms, Groups and Cohorts

  • Active Comparator: supplement
    • lutein supplement
  • Placebo Comparator: placebo
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Macular Pigment Optical Density
    • Time Frame: Baseline, 4 months, 8 months, 12 months

Secondary Measures

  • Visual Acuity
    • Time Frame: Baseline, 4 months, 8 months, 12 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Maastricht University Medical Center
  • Collaborator
    • Cognis Deutschland GmbH & Co. KG
  • Provider of Information About this Clinical Study
    • Dr. Christine Gärtner, Cognis Deutschland GmbH & Co. KG
  • Overall Official(s)
    • Tos TJM Berendschot, PhD, Principal Investigator, University Eye Clinic Maastricht
    • Ian J Murray, PhD, Principal Investigator, University of Manchester

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