The Influence of Lutein Supplements on Age-related Macular Degeneration

Age-Related Macular Degeneration Clinical Trial

Official title:

The Influence of Lutein Supplements on Age-related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042860
• Other study ID #: 061052
• Status: Completed
• Phase: N/A
• First received: January 5, 2010
• Last updated: January 7, 2010
• Start date: August 2007
• Est. completion date: August 2009

Study information

• Verified date: January 2010
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Dietary Supplement:
• Lutein
Lutein supplement, 10 mg daily
• Placebo
Placebo

Locations

Country	Name	City	State
Netherlands	University Eye Clinic Maastricht	Maastricht
United Kingdom	Faculty of Life Sciences, University of Manchester	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Cognis Deutschland GmbH & Co. KG

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular Pigment Optical Density		Baseline, 4 months, 8 months, 12 months	No
Secondary	Visual Acuity		Baseline, 4 months, 8 months, 12 months	No