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The Influence of Lutein Supplements on Age-related Macular Degeneration

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Age-Related Macular Degeneration

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Lutein

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Triple Blind

80 participants in 2 patient groups, including a placebo group

supplement
Active Comparator group
Description:
lutein supplement
Treatment:
Dietary Supplement: Lutein
placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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