The Influence of Lutein Supplements on Age-related Macular Degeneration

NCT ID: NCT01042860

Last Updated: 2010-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Age-Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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supplement

lutein supplement

Group Type ACTIVE_COMPARATOR

Lutein

Intervention Type DIETARY_SUPPLEMENT

Lutein supplement, 10 mg daily

placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Lutein

Lutein supplement, 10 mg daily

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cognis Deutschland GmbH & Co. KG

INDUSTRY

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Cognis Deutschland GmbH & Co. KG

Principal Investigators

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Tos TJM Berendschot, PhD

Role: PRINCIPAL_INVESTIGATOR

University Eye Clinic Maastricht

Ian J Murray, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

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University Eye Clinic Maastricht

Maastricht, , Netherlands

Site Status

Faculty of Life Sciences, University of Manchester

Manchester, , United Kingdom

Site Status

Countries

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Netherlands United Kingdom

References

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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.

Reference Type DERIVED
PMID: 23385792 (View on PubMed)

Other Identifiers

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061052

Identifier Type: -

Identifier Source: org_study_id

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