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
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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 |
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 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
starch in hard shell gelatine capsules
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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
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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
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Dietary Supplement: zeaxanthin plus lutein
one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks |
- 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.
- 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.
- 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.
- 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 ]
- 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
- Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks [ Time Frame: at baseline and 48 weeks during the intervention ]
- 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
- Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention [ Time Frame: at baseline, 24, 48 weeks and 2 years ]

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
China, Beijing | |
Haidian District | |
Beijing, Beijing, China, 100191 |
Principal Investigator: | Xiaoming Lin, M.M. | Peking University |
Responsible Party: | Xiaoming Lin, Study Principal Investigator, Peking University |
ClinicalTrials.gov Identifier: | NCT01528605 |
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 |
lutein zeaxanthin age-related macular degeneration supplementation |
macular pigment optical density visual function serum concentration |
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |