Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00154843
Status:
COMPLETED
Last Update Posted:
2008-01-14
First Post:
2005-09-08
Brief Title:
A Clinical Study to Determine Factors Affecting Absorption and Serum Levels of Lycopene After Supplementation
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Clinical Study to Determine Factors Affecting Absorption and Serum Levels of Lycopene After Supplementation
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary To determine factors that affect absorption and serum levels of lycopene after supplementation
Secondary
1 To evaluate general safety and tolerability of oral lycopene 15 or 30 mg per day for 12 weeks
2 To determine lycopene effects on reducing serum levels of prostate specific antigen PSA and on relieving lower urinary tract symptoms LUTS in relation to prostate hypertrophy as evaluated by the International Prostate Symptom Score I-PSS
Secondary
1 To evaluate general safety and tolerability of oral lycopene 15 or 30 mg per day for 12 weeks
2 To determine lycopene effects on reducing serum levels of prostate specific antigen PSA and on relieving lower urinary tract symptoms LUTS in relation to prostate hypertrophy as evaluated by the International Prostate Symptom Score I-PSS
Detailed Description:
This is an uncontrolled intervention study in which eligible male subjects N60 after a two-week washout will be randomized to receive lycopene either 15 or 30 mg per day for 12 weeks About equal numbers of subjects will be randomized to either 15 or 30 mg of lycopene about 30 subjects for each arm The study is expected to be finished in 2 year The study is expected to be finished in 2 year Concerning an expected dropout rate of 10 66 subjects will be recruited for the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None