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The Influence of Lutein Supplements on Age-related Macular Degeneration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01042860
First Posted: January 6, 2010
Last Update Posted: January 8, 2010
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.
Collaborator:
Cognis Deutschland GmbH & Co. KG
Information provided by:
Maastricht University Medical Center
  Purpose

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 Intervention
Age-Related Macular Degeneration Dietary Supplement: Lutein Dietary Supplement: Placebo

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

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

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

Enrollment: 80
Study Start Date: August 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: supplement
lutein supplement
Dietary Supplement: Lutein
Lutein supplement, 10 mg daily
Placebo Comparator: placebo
Placebo
Dietary Supplement: Placebo
Placebo

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01042860


Locations
Netherlands
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
Investigators
Principal Investigator: Tos TJM Berendschot, PhD University Eye Clinic Maastricht
Principal Investigator: Ian J Murray, PhD University of Manchester
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Christine Gärtner, Cognis Deutschland GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT01042860     History of Changes
Other Study ID Numbers: 061052
First Submitted: January 5, 2010
First Posted: January 6, 2010
Last Update Posted: January 8, 2010
Last Verified: January 2010

Keywords provided by Maastricht University Medical Center:
macular pigment
lutein
age-related macular degeneration
AMD

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases