Lutein/Zeaxanthin and Omega-3 Supplementation in Persons Over Age 60
Nyckelord
Abstrakt
Beskrivning
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.
Datum
Senast verifierad: | 08/14/2007 |
Först skickat: | 07/19/2005 |
Beräknad anmälan inlämnad: | 07/19/2005 |
Först publicerad: | 07/20/2005 |
Senaste uppdatering skickad: | 06/29/2017 |
Senaste uppdatering publicerad: | 07/01/2017 |
Faktiskt startdatum för studien: | 07/13/2005 |
Beräknat slutfört datum: | 08/14/2007 |
Tillstånd eller sjukdom
Intervention / behandling
Drug: Lutein
Fas
Urvalskriterier
Åldrar berättigade till studier | 60 Years Till 60 Years |
Kön som är berättigade till studier | All |
Accepterar friska volontärer | Ja |
Kriterier | - 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. |