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Clinical Trials/NCT00803699
NCT00803699
Completed
Not Applicable

Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels

USDA Grand Forks Human Nutrition Research Center1 site in 1 country262 target enrollmentNovember 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nutritional Requirements
Sponsor
USDA Grand Forks Human Nutrition Research Center
Enrollment
262
Locations
1
Primary Endpoint
Evaluation of effectiveness of consuming oral doses of L-selenomethionine in raising plasma selenium concentrations
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 2005
End Date
September 2007
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
USDA Grand Forks Human Nutrition Research Center
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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.(Baseline and after 12 months of supplementation)

Study Sites (1)

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