Lutein/Zeaxanthin and Omega-3 Supplementation in Persons Over Age 60
|First Received Date ICMJE||July 20, 2005|
|Last Updated Date||January 24, 2017|
|Start Date ICMJE||July 14, 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00121589 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Lutein/Zeaxanthin and Omega-3 Supplementation in Persons Over Age 60|
|Official Title ICMJE||Lutein/Zeaxanthin and Omega-3 Supplementation in Persons Over Age 60|
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 Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Macular Degeneration|
|Intervention ICMJE||Drug: Lutein|
|Study Arms||Not Provided|
|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.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||August 15, 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
|Ages||60 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00121589|
|Other Study ID Numbers ICMJE||050073
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Eye Institute (NEI)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 15, 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP