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The Influence of Lutein Supplements on Age-related Macular Degeneration

Primary Purpose

Age-Related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lutein
Placebo
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Age-Related Macular Degeneration focused on measuring macular pigment, lutein, age-related macular degeneration, AMD

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Eye Clinic Maastricht
  • Faculty of Life Sciences, University of Manchester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

supplement

placebo

Arm Description

lutein supplement

Placebo

Outcomes

Primary Outcome Measures

Macular Pigment Optical Density

Secondary Outcome Measures

Visual Acuity

Full Information

First Posted
January 5, 2010
Last Updated
January 7, 2010
Sponsor
Maastricht University Medical Center
Collaborators
Cognis Deutschland GmbH & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT01042860
Brief Title
The Influence of Lutein Supplements on Age-related Macular Degeneration
Official Title
The Influence of Lutein Supplements on Age-related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Maastricht University Medical Center
Collaborators
Cognis Deutschland GmbH & Co. KG

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
macular pigment, lutein, age-related macular degeneration, AMD

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
supplement
Arm Type
Active Comparator
Arm Description
lutein supplement
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Lutein
Intervention Description
Lutein supplement, 10 mg daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Macular Pigment Optical Density
Time Frame
Baseline, 4 months, 8 months, 12 months
Secondary Outcome Measure Information:
Title
Visual Acuity
Time Frame
Baseline, 4 months, 8 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tos TJM Berendschot, PhD
Organizational Affiliation
University Eye Clinic Maastricht
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ian J Murray, PhD
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Eye Clinic Maastricht
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
Faculty of Life Sciences, University of Manchester
City
Manchester
ZIP/Postal Code
M60 1QD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23385792
Citation
Murray IJ, Makridaki M, van der Veen RL, Carden D, Parry NR, Berendschot TT. Lutein supplementation over a one-year period in early AMD might have a mild beneficial effect on visual acuity: the CLEAR study. Invest Ophthalmol Vis Sci. 2013 Mar 11;54(3):1781-8. doi: 10.1167/iovs.12-10715.
Results Reference
derived

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The Influence of Lutein Supplements on Age-related Macular Degeneration

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