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Sponsors and Collaborators: |
USDA Grand Forks Human Nutrition Research Center National Cancer Institute (NCI) |
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Information provided by: | USDA Grand Forks Human Nutrition Research Center |
ClinicalTrials.gov Identifier: | NCT00803699 |
In this study, we will evaluate the effectiveness of several doses of oral selenomethionine in raising biomarkers of selenium status including plasma selenium concentrations.
Condition | Intervention |
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Nutritional Requirements |
Dietary Supplement: placebo Dietary Supplement: selenium as L-selenomethionine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Parallel Assignment, Bio-availability Study |
Official Title: | Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels |
Enrollment: | 262 |
Study Start Date: | November 2005 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo: Placebo Comparator
Capsule contains no selenium
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Dietary Supplement: placebo
daily placebo capsules for 12 months
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Selenium as L-selenomethionine: Active Comparator
50, 100, or 200 micrograms of selenium
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Dietary Supplement: selenium as L-selenomethionine
daily capsules of 50, 100, or 200 micrograms of L-selenomethionine for 12 months
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Results of studies with animal tumor models and human clinical trials suggest that the essential nutrient selenium can be anti-tumorigenic if consumed at levels greater than nutritional requirements. If it is possible to increase plasma selenium concentrations above 120 nanograms per milliliter with less than 200 micrograms of selenium daily, then it is possible that supplementation can be accomplished through the use of selenium-containing foods.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, North Dakota | |
USDA Grand Forks Human Nutrition Research Center | |
Grand Forks, North Dakota, United States, 58202 |
Principal Investigator: | Gerald F Combs, PhD | USDA Grand Forks Human Nutrition Research Center |
Responsible Party: | US Department of Agriculture ( Geral F Combs, Jr, PhD Center Director ) |
Study ID Numbers: | GFHNRC009, NCI Agreement#Y1-CN-2017-04 |
Study First Received: | December 3, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00803699 History of Changes |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
selenium |
Selenium Antioxidants Trace Elements Micronutrients |
Selenium Antioxidants Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs |
Trace Elements Micronutrients Protective Agents Pharmacologic Actions |