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

This study is currently recruiting participants.
Verified February 2012 by Peking University
Sponsor:
Information provided by (Responsible Party):
Xiaoming Lin, Peking University
ClinicalTrials.gov Identifier:
NCT01528605
First received: December 28, 2011
Last updated: February 4, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Age-related Macular Degeneration
 Dietary Supplement: placebo
Dietary Supplement: low lutein
Dietary Supplement: high lutein
Dietary Supplement: lutein plus zeaxanthin
Dietary Supplement: high zeaxanthin
Dietary Supplement: zeaxanthin plus lutein
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Lutein and Zeaxanthin Supplementations on Early Age-related Macular Degeneration

Resource links provided by NLM:

Drug Information available for: Lutein
U.S. FDA Resources

Further study details as provided by Peking University:

Primary Outcome Measures:
  • Changes of macular pigment optical density (MPOD) during 96 weeks [ Time Frame: at baseline and 24, 48, 96 weeks during the intervention ] [ Designated as safety issue: No ]
    the autofluorescence picture of subject's macular was analyzed by MATLAB for MPOD values


Secondary Outcome Measures:
  • Changes of serum xanthophylls concentrations during the intervention [ Time Frame: at baseline and 4, 12, 24, 48, 96 weeks during the intervention ] [ Designated as safety issue: No ]
    changes of serum xanthophylls concentrations measured by high performance liquid chromatograph (HPLC)at baseline and 4, 12, 24, 48 and 96 weeks during the intervention

  • Changes of best-spectacle corrected visual acuity (BSCVA) during the intervention [ Time Frame: at baseline and 24, 48, 96 weeks during the intervention ] [ Designated as safety issue: No ]
    best-spectacle corrected visual acuity (BSCVA) measured by ETDRS chart at baseline and 24, 48, 96 weeks during the intervention

  • Changes of contrast sensitivity (CSF) measured by CSV-100 during the intervention [ Time Frame: at baseline, 24, 48 and 96 weeks during the intervention ] [ Designated as safety issue: No ]
  • Changes of flash recovery time (FRT) measured by MDD-2 macular adaptometer [ Time Frame: at baseline, 24, 48 and 96 weeks during the intervention ] [ Designated as safety issue: No ]
    Flash recovery time (FRT) was measured by MDD-2 macular adaptometer at baseline, 24, 48 and 96 weeks

  • Changes from baseline in multifocal electroretinogram (mfERG) at 48 weeks [ Time Frame: at baseline and 48 weeks during the intervention ] [ Designated as safety issue: No ]
  • Changes from baseline in microperimetry (MP) in 96 weeks [ Time Frame: at baseline, 48 and 96 weeks during the intervention ] [ Designated as safety issue: No ]
    Microperimetry (MP) was measured by the MP1 Microperimeter

  • Changes of food pattern at baseline, 48 and 96 weeks by food frequency questionnaire [ Time Frame: at baseline, 48 and 96 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 162
Study Start Date: June 2010
Estimated Study Completion Date: June 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
starch in hard shell gelatine capsules
 Dietary Supplement: placebo
Placebo, one gelatine capsule containing starch per day, for 96 weeks
Experimental: Low lutein
low lutein group
 Dietary Supplement: low lutein
one gelatine capsule containing 10mg lutein per day, for 96 weeks
Experimental: High lutein
high lutein group
 Dietary Supplement: high lutein
one gelatine capsule containing 20mg lutein per day, for 96 weeks
Experimental: Low lutein zeaxanthin
lutein plus zeaxanthin group
 Dietary Supplement: lutein plus zeaxanthin
one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks
Experimental: High zeaxanthin
zeaxanthin group
 Dietary Supplement: high zeaxanthin
one gelatine capsule containing high zeaxanthin per day, for 48 weeks
Experimental: high lutein zeaxanthin
Zeaxanthin plus lutein group
 Dietary Supplement: zeaxanthin plus lutein
one gelatine capsule containing a different portion of lutein and zeaxanthin compared with LZ per day, for 48 weeks

Detailed Description:

Early age-related macular degeneration (AMD) is an early hallmark of irreversible vision impairment accompanying with senescence of macular. Given the fact in treatment, prevention strategy is thought to be an efficient and robust approach to diminish early AMD patients in low-income countries, however, feasible cocktail provision in most developing nations remain mysteries. Here we proposed an effective cocktail treatment with different amounts of lutein and zeaxanthin could increase the macular pigment optical density (MPOD) and serum xanthophylls concentrations among randomized Chinese AMD patients; and might improve visual function measured by visual performance indices such as best-spectacle corrected visual acuity (BSCVA), contrast sensitivity (CSF), flash recovery time (FRT), multifocal electroretinogram (mfERG) and microperimetry.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528605

Contacts
Contact: Yangmu Huang +86-15010376131 ymhuang@bjmu.edu.cn

Locations
China, Beijing
Haidian District Recruiting
Beijing, Beijing, China, 100191
Contact: Yangmu Huang, Doctor     +86-015010376131     ymhuang@bjmu.edu.cn    
Sponsors and Collaborators
Peking University
Investigators
Principal Investigator: Xiaoming Lin, M.M. Peking University
  More Information

No publications provided by Peking University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Xiaoming Lin, Study Principal Investigator, Peking University
ClinicalTrials.gov Identifier: NCT01528605     History of Changes
Other Study ID Numbers: NNSFC-30872113
Study First Received: December 28, 2011
Last Updated: February 4, 2012
Health Authority: China: National Natural Science Foundation

Keywords provided by Peking University:
lutein
zeaxanthin
age-related macular degeneration
supplementation
 macular pigment optical density
visual function
serum concentration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013