Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels

Not Applicable

Completed

• Conditions: Nutritional Requirements
• Interventions: Dietary Supplement: placebo; Dietary Supplement: selenium as L-selenomethionine

• Registration Number: NCT00803699
• Lead Sponsor: USDA Grand Forks Human Nutrition Research Center

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.

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Study First Submitted: 2008-12-03
• Study First Submitted QC: 2008-12-04
• Study First Posted: 2008-12-05
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-24
• Last Update Posted: 2018-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Capsule contains no selenium
Selenium as L-selenomethionine	selenium as L-selenomethionine	50, 100, or 200 micrograms of selenium

Primary Outcome Measures

Name	Time	Method
Evaluation of effectiveness of consuming oral doses of L-selenomethionine in raising plasma selenium concentrations	Baseline, and after 3, 6, 9, and 12 months of supplementation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

USDA Grand Forks Human Nutrition Research Center; 🇺🇸 Grand Forks, North Dakota, United States