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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiaoming Lin, Peking University
ClinicalTrials.gov Identifier:
NCT01528605
First received: December 28, 2011
Last updated: August 18, 2014
Last verified: August 2014

December 28, 2011
August 18, 2014
June 2010
September 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]

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.

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
Complete list of historical versions of study NCT01528605 on ClinicalTrials.gov Archive Site
  • Changes of Serum Xanthophylls Concentrations During the Intervention [ Time Frame: at baseline and 4, 12, 24 and 48 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 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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ 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) During the Intervention [ Time Frame: at baseline, 24, 48 weeks and 2 years during the intervention ] [ Designated as safety issue: No ]
    Microperimetry (MP) was measured by the MP1 Microperimeter
  • Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention [ Time Frame: at baseline, 24, 48 weeks and 2 years ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Effects of Lutein and Zeaxanthin Supplementation on Early Age-related Macular Degeneration
The Effects of Lutein and Zeaxanthin Supplementations on Early Age-related Macular Degeneration

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Age-related Macular Degeneration
  • Dietary Supplement: placebo
    Placebo, one gelatine capsule containing starch per day, for 96 weeks
  • Dietary Supplement: low lutein
    one gelatine capsule containing 10mg lutein per day, for 96 weeks
  • Dietary Supplement: high lutein
    one gelatine capsule containing 20mg lutein per day, for 96 weeks
  • Dietary Supplement: lutein plus zeaxanthin
    one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks
  • Dietary Supplement: high zeaxanthin
    one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks
  • Dietary Supplement: zeaxanthin plus lutein
    one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks
  • Placebo Comparator: Placebo
    starch in hard shell gelatine capsules
    Intervention: Dietary Supplement: placebo
  • Experimental: Low lutein
    low lutein group
    Intervention: Dietary Supplement: low lutein
  • Experimental: High lutein
    high lutein group
    Intervention: Dietary Supplement: high lutein
  • Experimental: Low lutein zeaxanthin
    lutein plus zeaxanthin group
    Intervention: Dietary Supplement: lutein plus zeaxanthin
  • Experimental: High zeaxanthin
    zeaxanthin group
    Intervention: Dietary Supplement: high zeaxanthin
  • Experimental: high lutein zeaxanthin
    Zeaxanthin plus lutein group
    Intervention: Dietary Supplement: zeaxanthin plus lutein
Ma L, Dou HL, Huang YM, Lu XR, Xu XR, Qian F, Zou ZY, Pang HL, Dong PC, Xiao X, Wang X, Sun TT, Lin XM. Improvement of retinal function in early age-related macular degeneration after lutein and zeaxanthin supplementation: a randomized, double-masked, placebo-controlled trial. Am J Ophthalmol. 2012 Oct;154(4):625-634.e1. doi: 10.1016/j.ajo.2012.04.014. Epub 2012 Jul 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
December 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01528605
NNSFC-30872113
Yes
Xiaoming Lin, Peking University
Peking University
Not Provided
Principal Investigator: Xiaoming Lin, M.M. Peking University
Peking University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP