N/A N=168 Randomized Quadruple-blind Prevention

Effects of Lutein and Zeaxanthin Supplementation on Early Age-related Macular Degeneration

Age-related Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT01528605 ↗

Enrolled (actual)

168

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years — 0.315; 0.307; 0.315; 0.320 density units — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: placebo (Dietary_supplement); low lutein (Dietary_supplement); high lutein (Dietary_supplement); lutein plus zeaxanthin (Dietary_supplement); high zeaxanthin (Dietary_supplement); zeaxanthin plus lutein (Dietary_supplement)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Peking University
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years	0.315; 0.307; 0.315; 0.320; 0.327; 0.300	<0.05 sig
SECONDARY Changes of Serum Xanthophylls Concentrations During the Intervention	0.330; 0.318; 0.301; 0.244; 0.258; 0.870	<0.05 sig
SECONDARY Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention	53.037; 54.769; 54.539; 56.840; 56.481; 55.038	>0.05
SECONDARY Changes of Contrast Sensitivity (CSF) Measured by CSV-100 During the Intervention	—	—
SECONDARY Changes of Flash Recovery Time (FRT) Measured by MDD-2 Macular Adaptometer	—	—
SECONDARY Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks	—	—
SECONDARY Changes From Baseline in Microperimetry (MP) During the Intervention	—	—
SECONDARY Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention	—	—

Summary

This study is to investigate the protective effects of supplemental lutein and zeaxanthin on early age-related macular degeneration (AMD) patients in China.

Eligibility Criteria

Inclusion Criteria

aged over 50 years, Chinese of the Han nationality
diagnosed as age-related macular degeneration
did not take lutein or zeaxanthin supplements in the past half a year
good general health
corrected visual acuity above 0.25 (20/80)
did not take optical laser or medical treatments

Exclusion Criteria

had other ocular diseases, such as glaucoma, macular pucker, optic neuropathy, diabetic retinopathy etc.
had nervous system diseases, stroke, Type I diabetes
had diseases effected nutrients absorption, such as Crohn' s disease
had turbid ocular media or transplanted intraocular lenses
reported abnormal digestive condition

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01528605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.