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A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia

NCT00178113 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-05-27

No results posted yet for this study

Summary

The purpose of this study is to determine whether dietary lycopene supplementation lowers serum prostate specific antigen(PSA) in men with high grade intraepithelial neoplasia (HGPIN).

Conditions

  • Prostatic Intraepithelial Neoplasia

Interventions

DRUG

- Lyc-O-Mato (dietary supplement, 30 mg lycopene/day)

DRUG

- Certagen (multivitamins with minerals)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Clareann H Bunker, PhD · University of Pittsburgh

  • Lewis H Kuller, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-07-31
Completion
2004-07-31

Countries

  • Trinidad and Tobago

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00178113 on ClinicalTrials.gov