Status:
COMPLETED
Lutein/Zeaxanthin and Omega-3 Supplementation in Persons Over Age 60
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Macular Degeneration
Eligibility:
All Genders
60+ years
Phase:
PHASE1
Brief 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 ...
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 (lu...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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.
- EXCLUSION CRITERIA:
- 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.
Exclusion
Key Trial Info
Start Date :
July 14 2005
Trial Type :
INTERVENTIONAL
End Date :
August 15 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00121589
Start Date
July 14 2005
End Date
August 15 2007
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892