Age-related Macular DegenerationNCT01528605
Effects of Lutein and Zeaxanthin Supplementation on Early Age-related Macular Degeneration
A study testing low lutein, high lutein and lutein plus zeaxanthin in people with Age-related Macular Degeneration, run by Peking University at 1 site in China.
Trial summary
This study is to investigate the protective effects of supplemental lutein and zeaxanthin on early age-related macular degeneration (AMD) patients in China. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- low lutein, high lutein and lutein plus zeaxanthin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- Jun 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Age-related Macular Degeneration
- Being tested
- placebo, low lutein, high lutein, lutein plus zeaxanthin, high zeaxanthin
- Keywords
- lutein, zeaxanthin, age-related macular degeneration, supplementation, macular pigment optical density, visual function, serum concentration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDietary supplement
Placebo, one gelatine capsule containing starch per day, for 96 weeks
low luteinDietary supplement
one gelatine capsule containing 10mg lutein per day, for 96 weeks
high luteinDietary supplement
one gelatine capsule containing 20mg lutein per day, for 96 weeks
lutein plus zeaxanthinDietary supplement
one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks
high zeaxanthinDietary supplement
one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks
zeaxanthin plus luteinDietary supplement
one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | starch in hard shell gelatine capsules Receives: Dietary Supplement: placebo |
| Low lutein | Experimental | low lutein group Receives: Dietary Supplement: low lutein |
| High lutein | Experimental | high lutein group Receives: Dietary Supplement: high lutein |
| Low lutein zeaxanthin | Experimental | lutein plus zeaxanthin group Receives: Dietary Supplement: lutein plus zeaxanthin |
| High zeaxanthin | Experimental | zeaxanthin group Receives: Dietary Supplement: high zeaxanthin |
| high lutein zeaxanthin | Experimental | Zeaxanthin plus lutein group Receives: Dietary Supplement: zeaxanthin plus lutein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years
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.
Measured: at baseline and 24 weeks, 48 weeks, 2 years during the intervention
Secondary outcomes (7)
Changes of Serum Xanthophylls Concentrations 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.
Measured: at baseline and 4, 12, 24 and 48 weeks during the intervention
Changes of Best-spectacle Corrected Visual Acuity (BSCVA) 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.
Measured: at baseline and 24 weeks, 48 weeks, 2 years during the intervention
Changes of Contrast Sensitivity (CSF) Measured by CSV-100 During the Intervention
Measured: at baseline, 24, 48 weeks and 2 years during the intervention
Changes of Flash Recovery Time (FRT) Measured by MDD-2 Macular Adaptometer
Flash recovery time (FRT) was measured by MDD-2 macular adaptometer at baseline, 24, 48 and 96 weeks
Measured: at baseline, 24, 48 weeks and 2 years during the intervention
Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks
Measured: at baseline and 48 weeks during the intervention
Changes From Baseline in Microperimetry (MP) During the Intervention
Microperimetry (MP) was measured by the MP1 Microperimeter
Measured: at baseline, 24, 48 weeks and 2 years during the intervention
Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention
Measured: at baseline, 24, 48 weeks and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startJun 2010
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoming Lin, Peking University
- Investigators
- Xiaoming Lin, M.M., Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528605
- Sponsor's protocol ID
- NNSFC-30872113
- Status last verified
- Aug 2014
- First submitted
- 28 Dec 2011
- Last updated
- 29 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22835510
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lutein and Zeaxanthin Supplementations on Early Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01528605
- Acronym / sponsor ID
- NNSFC-30872113
- Conditions
- Age-related Macular Degeneration
- Keywords
- lutein, zeaxanthin, age-related macular degeneration, supplementation, macular pigment optical density, visual function, serum concentration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Posted 29 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to investigate the protective effects of supplemental lutein and zeaxanthin on early age-related macular degeneration (AMD) patients in China.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: placebostarch in hard shell gelatine capsules |
| Low lutein | Experimental | Dietary Supplement: low luteinlow lutein group |
| High lutein | Experimental | Dietary Supplement: high luteinhigh lutein group |
| Low lutein zeaxanthin | Experimental | Dietary Supplement: lutein plus zeaxanthinlutein plus zeaxanthin group |
| High zeaxanthin | Experimental | Dietary Supplement: high zeaxanthinzeaxanthin group |
| high lutein zeaxanthin | Experimental | Dietary Supplement: zeaxanthin plus luteinZeaxanthin plus lutein group |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboPlacebo, one gelatine capsule containing starch per day, for 96 weeks | Dietary supplement | Placebo |
| low luteinone gelatine capsule containing 10mg lutein per day, for 96 weeks | Dietary supplement | Low lutein |
| high luteinone gelatine capsule containing 20mg lutein per day, for 96 weeks | Dietary supplement | High lutein |
| lutein plus zeaxanthinone gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks | Dietary supplement | Low lutein zeaxanthin |
| high zeaxanthinone gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks | Dietary supplement | High zeaxanthin |
| zeaxanthin plus luteinone gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks | Dietary supplement | high lutein zeaxanthin |
Primary outcome
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.
7 secondary outcomes
Changes of Serum Xanthophylls Concentrations During the Intervention
Time frame: at baseline and 4, 12, 24 and 48 weeks during the intervention
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
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
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
Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention
Time frame: at baseline, 24, 48 weeks and 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22835510Ma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoming Lin, M.M. principal investigator
Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low lutein, high lutein and lutein plus zeaxanthin in people with Age-related Macular Degeneration, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01528605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2014.