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OpenTrials
Completed

NCT Number: 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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Eye Clinic Maastricht, Maastricht, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lutein

Dietary Supplement

Lutein supplement, 10 mg daily

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. Macular Pigment Optical Density

    Time frame: Baseline, 4 months, 8 months, 12 months

Secondary outcomes

  1. Visual Acuity

    Time frame: Baseline, 4 months, 8 months, 12 months

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Cognis Deutschland GmbH & Co. KG

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 6, 2010
Registry last updated
Jan 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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