Status:
COMPLETED
Effects of Antioxidants on Human Macular Pigments
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Eye Health
Eligibility:
All Genders
50-70 years
Phase:
NA
Brief Summary
Age-related macular degeneration (AMD) is the leading cause of blindness in the United States. Low dietary intake or low blood levels of lutein and zeaxanthin, which are the only pigments found in the...
Eligibility Criteria
Inclusion
- Normal hematologic parameters, normal serum albumin, normal liver function, normal kidney function, absence of fat malabsorption and no drug intake which would interfere with fat absorption, metabolism or blood clotting
- non-smokers
Exclusion
- A history of kidney stones, active small bowel disease or resection, atrophic gastritis, hyperlipidemia, insulin-requiring diabetes, alcoholism, pancreatic disease, or bleeding disorders
- Exogenous hormone users
- weighing greater than 20% above or below the NHANES median standard
- subjects with serum lutein/zeaxanthin concentrations that are more than 150 % of median of normal population (as previously reported in NHANES III at same age group)
- early age related macular degeneration, cataract, or glaucoma except for those with age appropriate progression of the eye status.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00718653
Start Date
September 1 2004
End Date
December 1 2007
Last Update
March 3 2009
Active Locations (1)
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1
Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111