Status:
COMPLETED
Characterization of the Pharmacokinetics of Oral Selenium Compounds in Humans Before and Following Supplementation
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Cancer
Eligibility:
All Genders
20-60 years
Brief Summary
The chemopreventive efficacy of Se was tested in a 10-year human intervention trial; total and lung cancer mortality, total cancer incidence, colorectal cancer and prostate cancer incidence decreased....
Detailed Description
The chemopreventive efficacy of Se was tested in a 10-year human intervention trial; total and lung cancer mortality, total cancer incidence, colorectal cancer and prostate cancer incidence decreased....
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Those subjects with normal physical examinations and Se plasma levels within the eligible range will be invited to participate in the study.
- Men and women will be recruited according to the following eligibility criteria. Subjects must:
- be between the ages of 20 and 60 years;
- be in general good health as determined by a screening history and physical examination and laboratory tests with no history of gastrointestinal, hepatic, renal and/or hematologic diseases, cancer, coronary heart disease;
- be within 20% from their ideal weight as described in the Metlife Height and Weight Tables (1993);
- be consuming typical mixed diets;
- give informed consent; and
- be judged, based on a personal interview, as having a high probability of participating for the two-year eight month duration of the study.
- EXCLUSION CRITERIA:
- women: pregnant or lactating women; sexually active and not using contraceptives (e.g., condoms, oral contraceptives, diaphragm); planning to become pregnant during the experimental period; or post -menopausal (at least 6 months);
- taking antibiotics on a regular basis;
- have a history of taking Se supplements of more than 25 ug/d in the past year;
- current smoker, or stopped smoking within the last 6 months;
- on rigorous exercise or weight-reduction programs.
Exclusion
Key Trial Info
Start Date :
June 14 1999
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 23 2010
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00342966
Start Date
June 14 1999
End Date
July 23 2010
Last Update
July 2 2017
Active Locations (2)
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1
USDA
Beltsville, Maryland, United States
2
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892