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Age-related Macular DegenerationPhase 1/2NCT01048476

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

A Phase 1/2 study testing lutein and Lutein and zeaxanthin in people with Age-related Macular Degeneration, run by Peking University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Lutein is one of oxygenated carotenoids. Over the past few years, there has been increased interest in evaluating the effect of lutein for optimizing eye health. A large number of epidemiological studies support the notion that the high intake dietary of lutein is strongly associated with a decreased relative risk of… Read more about this study

Who is it for?
Ages 50 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Age-related Macular Degeneration
What is being tested?
lutein and Lutein and zeaxanthin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteChina
Study dates
Sep 2009to Oct 2012
Phase
Phase 1/2
Are there results?
None posted in the registry

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 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients with nonexudative AMD (either categories 2, 3 or 4 according to the AREDS criteria; in group 4 the eyes with no-advanced AMD will be included)
  • Age between 50 and 90 years
  • Able to understand and comply with the requirements of the trial
  • Visual acuity > 0.4
  • Subjects must agree to take only the nutritional supplement that is

Who cannot join

  • Currently enrolled in an ophthalmic clinical trial
  • Eyes with concomitant macular or choroidal disorders other than AMD and with indefinite signs of AMD
  • Eyes with a diagnosis of exudative AMD with active subretinal neovascularization (SRNV) or CNV lesions requiring laser photocoagulation in the study eye
  • Subjects with significant ocular lens opacities causing vision decrease
  • Subjects with amblyopia
  • Subjects with optic nerve disease (neuropathy, atrophy, papilledema), unstable glaucoma as defined by intraocular pressures greater than 25 mm Hg, 3 or more glaucoma medications, C/D of 0.8 or greater and visual fields consistent with glaucoma; history of retina-vitreous surgery, degenerative myopia, active posterior intraocular inflammatory disease, chronic use of topical ocular steroid medications, vasoproliferative retinopathies (other than AMD), rhegmatogenous retinal detachment, and inherited macular dystrophies
Show all 14Show fewer
  • Subjects with demand type pacemakers or epilepsy
  • Subjects with uncontrolled hypertension (defined as diastolic of 90 or greater and systolic of 150 or greater)
  • Subjects with recent history (within the previous year) of cerebral vascular disease
  • manifested with transient ischemic attacks (TIA's) or cerebral vascular accidents (CVA's)
  • Subjects with a history of AIDS
  • lutein supplementation within the last 3 months
  • Subjects who have had intraocular surgery in trial eye within 3 months prior to enrolling in the trial
  • Patients who are unwilling to adhere to visit examination schedules

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Peking university

    Beijing, Beijing Municipality, 100191

    le Ma, MD, male@bjmu.edu.cn

    Recruiting

Other trials in China

About this study

Lutein is one of oxygenated carotenoids. Over the past few years, there has been increased interest in evaluating the effect of lutein for optimizing eye health. A large number of epidemiological studies support the notion that the high intake dietary of lutein is strongly associated with a decreased relative risk of AMD.Moreover, findings from initial observational studies have now been followed by placebo-controlled intervention trials showing that dietary modification and supplementation with lutein result in increasing the macular pigment optical density, and may help to improve visual function in patients suffering from AMD.Currently, nutritional status and background information of lutein and zeaxanthin in Chinese population is lack. Little is known about the preventive and therapy benefits of lutein on visual function in the AMD populations. In particular, the effect on visual function of relatively certain doses of lutein and zeaxanthin is unknown. Therefore, the objective of the present study was to examine the effect of consuming different doses of lutein on MPOD and visual function in AMD.

Read the detailed description

We aim to study the effect and the mechanism of lutein in the prevention and treatment for age-related macular degeneration (AMD). Using the cluster sampling method, baseline characteristics screening will be performed in Han nationality men and women in the suburban areas of Beijing, ranging in age from 50 to79 years. According to clinical diagnosis standard of AMD, AMD (n=120) and normal subjects (n=40) will be randomly selected to measure serum lutein and nutritional status, and evaluate the relationship between lutein and AMD. Each subject of AMD will be randomly assigned to 1 of 4 groups: Group low lutein (Group LL); Group high lutein (Group HL); Group lutein/zeaxanthin (Group LZ); and Group Placebo to participate in the randomized, double-blind, placebo-controlled, 1 year intervention study, respectively. Macular pigment optical density,related symptoms and multifocal electroretinogram (mfERG) will be measured at at weeks 0, 24 and 48, to compare their dynamic changes in response to supplements at baseline and each follow-up visit, observe time- and dose-response correlation of supplementation with lutein, assess the efficacy, dosage of lutein and/or zeaxanthin supplement.

Being tested
lutein, placebo, Lutein and zeaxanthin
Keywords
AMD
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • luteinDietary supplement

    Dietary Supplement: 20mg Lutein; daily supplementation one year

  • LuteinDietary supplement

    Dietary Supplement: 10mg Lutein; daily supplementation one year

  • placeboDietary supplement

    Dietary Supplement: placebo; daily supplementation one year

  • Lutein and zeaxanthinDrug

    Dietary Supplement: 10mg Lutein and 10mg zeaxanthin; daily supplementation one year

Study groups in NCT01048476
Study groupRoleWhat they receive
Group L20Active comparatorDietary Supplement: 20mg Lutein; daily supplementation one year
Receives: Dietary Supplement: lutein
Group L10Active comparatorDietary Supplement: 10mg Lutein; daily supplementation one year
Receives: Dietary Supplement: Lutein
Group PlaceboPlacebo comparatorDietary Supplement: Placebo, 0 mg Lutein
Receives: Dietary Supplement: placebo
Active Comparator: Group LZActive comparatorDietary Supplement: 10mg Lutein and 10mg zeaxanthin; daily supplementation one year
Receives: Drug: Lutein and zeaxanthin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MPOD and multifocal electroretinograms

    Measured: 1 year

Secondary outcomes (1)

  1. the safety and efficacy of lutein in reducing the risk of the development of advanced AMD.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2010 (estimated)
  2. Study startSep 2009
  3. Primary completionApr 2012 (estimated)
  4. Study completionOct 2012 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01048476
Sponsor's protocol ID
NSFC30872113
Status last verified
Mar 2012
First submitted
12 Jan 2010
Last updated
16 Mar 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.

    PubMed 37702300

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing lutein and Lutein and 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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 16 Mar 2012. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MPOD and multifocal electroretinograms (time frame: 1 year). 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 NCT01048476, 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 16 Mar 2012.

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