Macular DegenerationPhase 1NCT00121589
Lutein/Zeaxanthin and Omega-3 Supplementation in Persons Over Age 60
A Phase 1 study testing Lutein in people with Macular Degeneration, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
This study will explore whether taking the vitamins lutein and zeaxanthin, with or without Omega-3 fatty acid (fish oil or docosahexanoic acid, also known as DHA) will change the amount of lutein and zeaxanthin in the blood among people with age-related macular degeneration (AMD). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Lutein
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2005to 15 Aug 2007
- Phase
- Phase 1
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will range from those with no AMD and little or no drusen in either eye through end stage AMD (geographic atrophic, retinal pigment epithelial detachment, or other signs of neovascular/exudative disease) in one eye. AMD severity will be classified using AREDS criteria for the definition of advanced AMD. Children are not included because AMD is, by definition, an adult disease and the study is designed to assess the effect of oral administration of lutein in persons in the age group affected by AMD.
- Men and women aged 60 years or older.
- Eligible participants may have no evidence of AMD with little or no drusen in either eye, or may have any stage of AMD through end stage (geographic atrophic, retinal pigment epithelial detachment, or other signs of neovascular/exudative disease) in one eye.
- The ability to understand and sign an informed consent form prior to enrollment.
- People who currently smoke are eligible to enroll in this study. However, if smokers take an AREDS-like supplement, they must not take the AREDS-like supplement during the study.
Who cannot join
- Ocular disease (other than AMD) which confounds assessment of the retina including diabetic retinopathy, central serous choroidopathy, optic atrophy, retinal vein occlusion, active uveitis, significant explained or unexplained visual field loss, or any other type of retinopathy or retinal degeneration.
- Chronic requirement for any systemic or ocular medication for other eye diseases such as glaucoma.
- Regular use of lutein/zeaxanthin of 6 mg or more: during the last 3 months or currently taking these supplements. The daily use of the new Centrum or Centrum Silver or other similar multivitamins will be allowed but is limited to a maximum of twice a day.
- Participant has regularly taken 1 gm of fish oil (DHA, EPA) during the last 3 months or currently taking fish oil supplementation
- Inability or unwillingness to be followed for the nine-month study period.
- Acute, potentially life-threatening illness such as heart attack in the last year, or malignancy or blood disease not in remission.
- Any history of lung cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
This study will explore whether taking the vitamins lutein and zeaxanthin, with or without Omega-3 fatty acid (fish oil or docosahexanoic acid, also known as DHA) will change the amount of lutein and zeaxanthin in the blood among people with age-related macular degeneration (AMD). AMD is one of the leading causes of legal blindness among people over the age of 50 in developed countries. In the disease, the retina of the eye, the sensory portion, worsens in condition. AMD causes progressive loss of central vision, with only peripheral vision remaining, that is, the ability for someone to see from the edges of the eye. To date, there is not any effective treatment to improve vision for most people whose AMD is advanced. Yet some data from research studies suggest a possible role of antioxidants, including lutein, in reducing the risk of AMD and cataracts. Lutein and zeaxanthin belong to the carotenoid family of vitamins, of which there are more than 600. There are 40 or 50 carotenoids in the typical diet of human beings, but only 14 major dietary ones are identified in human plasma. Lutein, in particular, is a vitamin that is found naturally in the retina, especially in the macula, the region of the eye that is essential for fine, detailed vision. Previous studies have shown that higher levels of foods rich in Omega-3 fatty acid were associated with a lower likelihood of AMD.
Patients ages 60 and older who may or may not have AMD, who do not have certain other serious eye disorders, and who have not had potentially life-threatening illness in the last year may be eligible for this study. About 40 people will participate.
Read more
Patients will undergo a medical history and physical examination. A blood collection of about 4 tablespoons will be done to measure the amount of lutein and other vitamins in the blood. Patients will have a complete eye examination consisting of procedures standard to those given by ophthalmologists. Participants will have photographs taken of their eyes, and they will undergo a visual field test. Flicker photometry also will be conducted. This consists of the patients looking at a flashing bluish light with one eye at a time, and turning a knob until the light stops flashing. Then during the test, patients will look away from the light and turn the knob until the flashing stops.
During this study study, patients will be asked to not take more than two tablets each day of multivitamins that contain lutein. The vitamin supplements will be provided as pills that represent one of two vitamin regimens given on a random basis: either lutein and zeaxanthin with DHA or lutein and zeaxanthin without DHA added. The amounts would be 10 mg/day of lutein and 2 mg/day of zeaxanthin, with or without 1 g/day of DHA. Patients will return to the study center for follow-up visits at 1 month, 3 months, 6 months, and 9 months. During those visits, some of the examinations done earlier will be repeated so that the researchers can evaluate the effects of supplements on patients' eyes. Patients will also be watched for possible side effects from the vitamins supplements. Lutein and zeaxanthin supplements are considered to be safe with possible minor side effects, such as headaches and difficulty in swallowing the tablets. Fish oil or DHA supplements may also cause abdominal discomfort.
If information obtained from this study may be important for participants' health, they will be informed when it is available. There are no plans to give participants the results of any medical tests, evaluations, or other research data. Further research may be necessary before such results become meaningful.
Read the detailed description
The current proposed study is a necessary pilot study to prepare for a large-scale phase III randomized clinical trial planned to investigate whether oral supplementation with macular xanthophylls (lutein and zeaxanthin) and omega-3 long-chain polyunsaturated fatty acids (LCPUFAs) will decrease the progression of age-related macular degeneration (AMD) when compared to placebo. The primary objective of this pilot study is to investigate whether additional oral supplementation of omega-3 LCPUFAs (1 g/day) to daily supplementation of lutein (10 mg/day) and zeaxanthin (2 mg/day) will change the plasma levels of lutein and zeaxanthin in participants over age 60. The secondary objective is to study whether changes in serum levels of xanthophylls, lutein and zeaxanthin following oral supplementation will result in changes in the macular pigment density. In this study, forty participants (20 participants per arm) will take the study medications of lutein (10 mg/day) and zeaxanthin (2 mg/day) with or without the omega-3 LCPUFAs (1 g/day) for 6 months and will be followed for a total of 9 months (the initial 6 months with supplementation and the last 3 months without supplementation). Participants will range from those with no AMD and little or no drusen in either eye through advanced AMD (geographic atrophic, retinal pigment epithelial detachment, or other signs of neovascular/exudative disease) in one eye. AMD severity will be classified using Age-Related Eye Disease Study (AREDS) criteria for the definition of advanced AMD. This is a preliminary study to be conducted prior to a large-scale phase III randomized clinical trial of omega -3 LCPUFAs and lutein/zeaxanthin for patients with moderate to high risk of AMD. The estimates of increases in serum lutein and zeaxanthin levels and the corresponding changes of macular pigment densities will provide essential information in conducting a large phase III randomized trial.
- Conditions
- Macular Degeneration
- Being tested
- Lutein
- Keywords
- AMD, Macular Pigment, Serum Lutein Levels, Vitamin Supplementation, Carotenoids, Lutein, Zeaxanthin, DHA, Age Related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuteinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study start14 Jul 2005
- Study completion15 Aug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121589
- Sponsor's protocol ID
- 050073
- Other IDs
- 05-EI-0073
- Status last verified
- 15 Aug 2007
- First submitted
- 20 Jul 2005
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Bone RA, Landrum JT, Hime GW, Cains A, Zamor J. Stereochemistry of the human macular carotenoids. Invest Ophthalmol Vis Sci. 1993 May;34(6):2033-40.
PubMed 8491553
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lutein/Zeaxanthin and Omega-3 Supplementation in Persons Over Age 60
- ClinicalTrials.gov ID
- NCT00121589
- Acronym / sponsor ID
- 050073
- Conditions
- Macular Degeneration
- Keywords
- AMD, Macular Pigment, Serum Lutein Levels, Vitamin Supplementation, Carotenoids, Lutein, Zeaxanthin, DHA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 14 Jul 2005
- Study completion
- 15 Aug 2007
- First posted
- 21 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will explore whether taking the vitamins lutein and zeaxanthin, with or without Omega-3 fatty acid (fish oil or docosahexanoic acid, also known as DHA) will change the amount of lutein and zeaxanthin in the blood among people with age-related macular degeneration (AMD). AMD is one of the leading causes of legal blindness among people over the age of 50 in developed countries. In the disease, the retina of the eye, the sensory portion, worsens in condition. AMD causes progressive loss of central vision, with only peripheral vision remaining, that is, the ability for someone to see from the edges of the eye. To date, there is not any effective treatment to improve vision for most people whose AMD is advanced. Yet some data from research studies suggest a possible role of antioxidants, including lutein, in reducing the risk of AMD and cataracts. Lutein and zeaxanthin belong to the carotenoid family of vitamins, of which there are more than 600. There are 40 or 50 carotenoids in the typical diet of human beings, but only 14 major dietary ones are identified in human plasma. Lutein, in particular, is a vitamin that is found naturally in the retina, especially in the macula, the region of the eye that is essential for fine, detailed vision. Previous studies have shown that higher levels of foods rich in Omega-3 fatty acid were associated with a lower likelihood of AMD.
Patients ages 60 and older who may or may not have AMD, who do not have certain other serious eye disorders, and who have not had potentially life-threatening illness in the last year may be eligible for this study. About 40 people will participate.
Patients will undergo a medical history and physical examination. A blood collection of about 4 tablespoons will be done to measure the amount of lutein and other vitamins in the blood. Patients will have a complete eye examination consisting of procedures standard to those given by ophthalmologists. Participants will have photographs taken of their eyes, and they will undergo a visual field test. Flicker photometry also will be conducted. This consists of the patients looking at a flashing bluish light with one eye at a time, and turning a knob until the light stops flashing. Then during the test, patients will look away from the light and turn the knob until the flashing stops.
During this study study, patients will be asked to not take more than two tablets each day of multivitamins that contain lutein. The vitamin supplements will be provided as pills that represent one of two vitamin regimens given on a random basis: either lutein and zeaxanthin with DHA or lutein and zeaxanthin without DHA added. The amounts would be 10 mg/day of lutein and 2 mg/day of zeaxanthin, with or without 1 g/day of DHA. Patients will return to the study center for follow-up visits at 1 month, 3 months, 6 months, and 9 months. During those visits, some of the examinations done earlier will be repeated so that the researchers can evaluate the effects of supplements on patients' eyes. Patients will also be watched for possible side effects from the vitamins supplements. Lutein and zeaxanthin supplements are considered to be safe with possible minor side effects, such as headaches and difficulty in swallowing the tablets. Fish oil or DHA supplements may also cause abdominal discomfort.
If information obtained from this study may be important for participants' health, they will be informed when it is available. There are no plans to give participants the results of any medical tests, evaluations, or other research data. Further research may be necessary before such results become meaningful.
Detailed description
The current proposed study is a necessary pilot study to prepare for a large-scale phase III randomized clinical trial planned to investigate whether oral supplementation with macular xanthophylls (lutein and zeaxanthin) and omega-3 long-chain polyunsaturated fatty acids (LCPUFAs) will decrease the progression of age-related macular degeneration (AMD) when compared to placebo. The primary objective of this pilot study is to investigate whether additional oral supplementation of omega-3 LCPUFAs (1 g/day) to daily supplementation of lutein (10 mg/day) and zeaxanthin (2 mg/day) will change the plasma levels of lutein and zeaxanthin in participants over age 60. The secondary objective is to study whether changes in serum levels of xanthophylls, lutein and zeaxanthin following oral supplementation will result in changes in the macular pigment density. In this study, forty participants (20 participants per arm) will take the study medications of lutein (10 mg/day) and zeaxanthin (2 mg/day) with or without the omega-3 LCPUFAs (1 g/day) for 6 months and will be followed for a total of 9 months (the initial 6 months with supplementation and the last 3 months without supplementation). Participants will range from those with no AMD and little or no drusen in either eye through advanced AMD (geographic atrophic, retinal pigment epithelial detachment, or other signs of neovascular/exudative disease) in one eye. AMD severity will be classified using Age-Related Eye Disease Study (AREDS) criteria for the definition of advanced AMD. This is a preliminary study to be conducted prior to a large-scale phase III randomized clinical trial of omega -3 LCPUFAs and lutein/zeaxanthin for patients with moderate to high risk of AMD. The estimates of increases in serum lutein and zeaxanthin levels and the corresponding changes of macular pigment densities will provide essential information in conducting a large phase III randomized trial.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants will range from those with no AMD and little or no drusen in either eye through end stage AMD (geographic atrophic, retinal pigment epithelial detachment, or other signs of neovascular/exudative disease) in one eye. AMD severity will be classified using AREDS criteria for the definition of advanced AMD. Children are not included because AMD is, by definition, an adult disease and the study is designed to assess the effect of oral administration of lutein in persons in the age group affected by AMD.
- Men and women aged 60 years or older.
- Eligible participants may have no evidence of AMD with little or no drusen in either eye, or may have any stage of AMD through end stage (geographic atrophic, retinal pigment epithelial detachment, or other signs of neovascular/exudative disease) in one eye.
- The ability to understand and sign an informed consent form prior to enrollment.
- People who currently smoke are eligible to enroll in this study. However, if smokers take an AREDS-like supplement, they must not take the AREDS-like supplement during the study.
Key exclusion criteria (7 listed)
- Ocular disease (other than AMD) which confounds assessment of the retina including diabetic retinopathy, central serous choroidopathy, optic atrophy, retinal vein occlusion, active uveitis, significant explained or unexplained visual field loss, or any other type of retinopathy or retinal degeneration.
- Chronic requirement for any systemic or ocular medication for other eye diseases such as glaucoma.
- Regular use of lutein/zeaxanthin of 6 mg or more: during the last 3 months or currently taking these supplements. The daily use of the new Centrum or Centrum Silver or other similar multivitamins will be allowed but is limited to a maximum of twice a day.
- Participant has regularly taken 1 gm of fish oil (DHA, EPA) during the last 3 months or currently taking fish oil supplementation
- Inability or unwillingness to be followed for the nine-month study period.
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 |
|---|---|---|
| Lutein | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 8491553Bone RA, Landrum JT, Hime GW, Cains A, Zamor J. Stereochemistry of the human macular carotenoids. Invest Ophthalmol Vis Sci. 1993 May;34(6):2033-40.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lutein in people with Macular Degeneration, run by National Eye Institute (NEI) at 1 site in United States.
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 7 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 2 Jul 2017. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00121589, 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 2 Jul 2017.