Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels

Nutritional Requirements Clinical Trial

— LoDoSe  

Official title:

Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803699
• Other study ID #: GFHNRC009
• Secondary ID: NCI Agreement#Y1
• Status: Completed
• Phase: N/A
• Start date: November 2005
• Est. completion date: September 2007

Study information

• Verified date: May 2018
• Source: USDA Grand Forks Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nutritional Requirements

Intervention

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

Locations

Country	Name	City	State
United States	USDA Grand Forks Human Nutrition Research Center	Grand Forks	North Dakota

Sponsors (2)

Lead Sponsor	Collaborator
USDA Grand Forks Human Nutrition Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Jackson MI, Combs GF Jr. Selenium and anticarcinogenesis: underlying mechanisms. Curr Opin Clin Nutr Metab Care. 2008 Nov;11(6):718-26. doi: 10.1097/MCO.0b013e3283139674. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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