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

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ClinicalTrials.gov Identifier: NCT01528605
Recruitment Status : Completed
First Posted : February 8, 2012
Results First Posted : August 29, 2014
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Xiaoming Lin, Peking University

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

Condition or disease Intervention/treatment 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 Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Lutein and Zeaxanthin Supplementations on Early Age-related Macular Degeneration
Study Start Date : June 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein

Arms and Interventions
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Arm Intervention/treatment
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 10mg zeaxanthin per day, for 48 weeks
Experimental: high lutein zeaxanthin
Zeaxanthin plus lutein group
 Dietary Supplement: zeaxanthin plus lutein
one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years [ Time Frame: at baseline and 24 weeks, 48 weeks, 2 years during the intervention ]

    Macular pigment is found in the center of the retina known as the macula and is made up of the carotenoids lutein and zeaxanthin. This pigment serves to protect the macula from harmful blue light. The MPOD ranges from 0 to 1, with higher scores corresponding with greater density (protection). The autofluorescence picture of subject's macular was analyzed for MPOD values.

    4 participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.



Secondary Outcome Measures :
  1. Changes of Serum Xanthophylls Concentrations During the Intervention [ Time Frame: at baseline and 4, 12, 24 and 48 weeks during the intervention ]
    Changes of serum xanthophylls concentrations measured by high performance liquid chromatograph (HPLC)at baseline and 4, 12, 24 and 48 weeks during the first 48 weeks of intervention.Four participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.

  2. Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention [ Time Frame: at baseline and 24 weeks, 48 weeks, 2 years during the intervention ]
    best-spectacle corrected visual acuity (BSCVA) measured by ETDRS chart at baseline and 24 weeks, 48 weeks, 2 years during the intervention. Four participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.

  3. Changes of Contrast Sensitivity (CSF) Measured by CSV-100 During the Intervention [ Time Frame: at baseline, 24, 48 weeks and 2 years during the intervention ]
  4. Changes of Flash Recovery Time (FRT) Measured by MDD-2 Macular Adaptometer [ Time Frame: at baseline, 24, 48 weeks and 2 years during the intervention ]
    Flash recovery time (FRT) was measured by MDD-2 macular adaptometer at baseline, 24, 48 and 96 weeks

  5. Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks [ Time Frame: at baseline and 48 weeks during the intervention ]
  6. Changes From Baseline in Microperimetry (MP) During the Intervention [ Time Frame: at baseline, 24, 48 weeks and 2 years during the intervention ]
    Microperimetry (MP) was measured by the MP1 Microperimeter

  7. Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention [ Time Frame: at baseline, 24, 48 weeks and 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528605


Locations
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China, Beijing
Haidian District
Beijing, Beijing, China, 100191
Sponsors and Collaborators
Peking University
Investigators
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Principal Investigator: Xiaoming Lin, M.M. Peking University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Xiaoming Lin, Study Principal Investigator, Peking University
ClinicalTrials.gov Identifier: NCT01528605     History of Changes
Other Study ID Numbers: NNSFC-30872113
First Posted: February 8, 2012    Key Record Dates
Results First Posted: August 29, 2014
Last Update Posted: August 29, 2014
Last Verified: August 2014
Keywords provided by Xiaoming Lin, Peking University:
lutein
zeaxanthin
age-related macular degeneration
supplementation
 macular pigment optical density
visual function
serum concentration
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases