Official Title: “Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels”

In this study, we will evaluate the effectiveness of several doses of oral selenomethionine in raising biomarkers of selenium status including plasma selenium concentrations.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Study Primary Completion Date: September 2007

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.

Intervention(s) in this Clinical Trial

• Dietary Supplement: placebo
  • daily placebo capsules for 12 months
• Dietary Supplement: selenium as L-selenomethionine
  • daily capsules of 50, 100, or 200 micrograms of L-selenomethionine for 12 months

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Placebo
  • Capsule contains no selenium
• Active Comparator: Selenium as L-selenomethionine
  • 50, 100, or 200 micrograms of selenium

Primary Measures

• Evaluation of effectiveness of consuming oral doses of L-selenomethionine in raising plasma selenium concentrations
  • Time Frame: Baseline, and after 3, 6, 9, and 12 months of supplementation
    Safety Issue?: No

Secondary Measures

• Biomarkers of selenium status will be determined in urine, buccal cells, and plasma. White blood cells will be analyzed to identify DNA damage, reflecting the degree of oxidative damage and evaluate the status of antioxidant repair mechanisms.
  • Time Frame: Baseline and after 12 months of supplementation
    Safety Issue?: No

Inclusion Criteria:

• able to swallow capsules
• body mass index less than 40

Exclusion Criteria:

• Pregnancy
• Chronic liver or kidney disease
• taking medication that might affect liver and/or kidney
• blood pressure 140/90 or higher
• already taking more than 50 micrograms of selenium

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: USDA Grand Forks Human Nutrition Research Center

Overall Clinical Trial Officials and Contacts

Gerald F Combs, PhD Principal Investigator USDA Grand Forks Human Nutrition Research Center  

Information obtained from ClinicalTrials.gov on September 01, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00803699

Study ID Number: GFHNRC009

ClinicalTrials.gov Identifier: NCT00803699

Health Authority: United States: Federal Government