Antioxidant Systems and Age-Related Macular Degeneration
Recruitment status was Recruiting
Tracking Information | |||||||||
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First Received Date ICMJE | April 24, 2008 | ||||||||
Last Updated Date | April 22, 2010 | ||||||||
Start Date ICMJE | June 2006 | ||||||||
Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
The purpose of this study is to find out if there are changes in the blood that would make you at risk for having age related macular degeneration. [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00668213 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE | |||||||||
Original Secondary Outcome Measures ICMJE | |||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Antioxidant Systems and Age-Related Macular Degeneration | ||||||||
Official Title ICMJE | Antioxidant Systems and Age-Related Macular Degeneration | ||||||||
Brief Summary | Objective: The objective of this study was to determine whether the antioxidant supplements used in AREDS shifted the plasma pool of the AREDS subjects to a more reduced state. The AREDS subjects were randomly assigned to one of four treatment groups:
None of the subjects received supplemental GSH or cyst (e) ine. Age-related macular degeneration (AMD) is the leading cause of severe visual impairment in elderly Americans, with an estimated 15 million people having some form of this disease. AMD primarily affects the central vision and many patients develop severe visual handicaps. Currently there are no clear established understandings of the etiology or pathogenesis of this disease. |
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Detailed Description | Inclusion Criteria
Exclusion Criteria
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Study Type ICMJE | Observational | ||||||||
Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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Biospecimen | Retention: Samples Without DNA Description: Blood serum |
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Sampling Method | Probability Sample | ||||||||
Study Population | Subjects at risk of macular degeneration |
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Condition ICMJE | Macular Degeneration | ||||||||
Intervention ICMJE | |||||||||
Study Group/Cohort (s) | |||||||||
Publications * | Brantley MA Jr, Osborn MP, Sanders BJ, Rezaei KA, Lu P, Li C, Milne GL, Cai J, Sternberg P Jr. The short-term effects of antioxidant and zinc supplements on oxidative stress biomarker levels in plasma: a pilot investigation. Am J Ophthalmol. 2012 Jun;153(6):1104-9.e2. Epub 2012 Mar 3. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 140 | ||||||||
Estimated Completion Date | June 2011 | ||||||||
Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 55 Years to 85 Years | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00668213 | ||||||||
Other Study ID Numbers ICMJE | 060471 | ||||||||
Has Data Monitoring Committee | No | ||||||||
Responsible Party | Paul Sternberg, MD, Vanderbilt University | ||||||||
Study Sponsor ICMJE | Vanderbilt University | ||||||||
Collaborators ICMJE | National Institutes of Health (NIH) | ||||||||
Investigators ICMJE |
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Information Provided By | Vanderbilt University | ||||||||
Verification Date | April 2010 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |