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The Influence of Lutein Supplements on Age-related Macular Degeneration

This study has been completed.
Sponsor:
Collaborator:
Cognis Deutschland GmbH & Co. KG
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01042860
First received: January 5, 2010
Last updated: January 7, 2010
Last verified: January 2010
History of Changes
  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: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Influence of Lutein Supplements on Age-related Macular Degeneration

Resource links provided by NLM:

Drug Information available for: Lutein
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: Baseline, 4 months, 8 months, 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Maastricht University Medical Center

Additional 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
Study First Received: January 5, 2010
Last Updated: January 7, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on May 16, 2013