The Influence of Lutein Supplements on Age-related Macula... | NCT01042860

Studies
The Influence of Lutein Supplements on Age-related Macular Degeneration

NCT01042860

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Jan 8, 2010Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

Age-Related Macular Degeneration

Interventions

Lutein
Placebo

Countries

Netherlands
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Jan 5, 2010

First Submission Date that Met QC Criteria

Jan 5, 2010

First Posted Date

Jan 6, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2010

Last Update Posted Date

Jan 8, 2010Estimated

Name	Class
Cognis Deutschland GmbH & Co. KG	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
supplement	Active Comparator	lutein supplement	Dietary Supplement: Lutein
placebo	Placebo Comparator	Placebo	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lutein	Dietary Supplement	Lutein supplement, 10 mg daily	supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Macular Pigment Optical Density		Baseline, 4 months, 8 months, 12 months

Secondary Outcomes

Measure	Description	Time Frame
Visual Acuity		Baseline, 4 months, 8 months, 12 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tos TJM Berendschot, PhD	University Eye Clinic Maastricht	Principal Investigator
Ian J Murray, PhD	University of Manchester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Eye Clinic Maastricht		Maastricht		6202 AZ	Netherlands
Faculty of Life Sciences, University of Manchester

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23385792	Derived	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.

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

ID	Term
D024341	Xanthophylls
D002338	Carotenoids
D011090	Polyenes
D000475	Alkenes
D006839