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The Influence of Lutein Supplements on Age-related Macular Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01042860
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : January 8, 2010
Cognis Deutschland GmbH & Co. KG
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Dietary Supplement: Lutein Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Influence of Lutein Supplements on Age-related Macular Degeneration
Study Start Date : August 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein

Arm Intervention/treatment
Active Comparator: supplement
lutein supplement
Dietary Supplement: Lutein
Lutein supplement, 10 mg daily

Placebo Comparator: placebo
Dietary Supplement: Placebo

Primary Outcome Measures :
  1. Macular Pigment Optical Density [ Time Frame: Baseline, 4 months, 8 months, 12 months ]

Secondary Outcome Measures :
  1. Visual Acuity [ Time Frame: Baseline, 4 months, 8 months, 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01042860

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University Eye Clinic Maastricht
Maastricht, Netherlands, 6202 AZ
United Kingdom
Faculty of Life Sciences, University of Manchester
Manchester, United Kingdom, M60 1QD
Sponsors and Collaborators
Maastricht University Medical Center
Cognis Deutschland GmbH & Co. KG
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Principal Investigator: Tos TJM Berendschot, PhD University Eye Clinic Maastricht
Principal Investigator: Ian J Murray, PhD University of Manchester
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Christine Gärtner, Cognis Deutschland GmbH & Co. KG Identifier: NCT01042860    
Other Study ID Numbers: 061052
First Posted: January 6, 2010    Key Record Dates
Last Update Posted: January 8, 2010
Last Verified: January 2010
Keywords provided by Maastricht University Medical Center:
macular pigment
age-related macular degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases