Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels - Full Text View

Sponsors and Collaborators:	USDA Grand Forks Human Nutrition Research Center National Cancer Institute (NCI)
Information provided by:	USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:	NCT00803699

Purpose

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
Nutritional Requirements	Dietary Supplement: placebo Dietary Supplement: selenium as L-selenomethionine

MedlinePlus related topics: Dietary Supplements Diets

Drug Information available for: Selenomethionine Selenium

U.S. FDA Resources

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

Further study details as provided by USDA Grand Forks Human Nutrition Research Center:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

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
Placebo: Placebo Comparator Capsule contains no selenium	Dietary Supplement: placebo daily placebo capsules for 12 months
Selenium as L-selenomethionine: Active Comparator 50, 100, or 200 micrograms of selenium	Dietary Supplement: selenium as L-selenomethionine daily capsules of 50, 100, or 200 micrograms of L-selenomethionine for 12 months

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803699

Locations

United States, North Dakota
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, United States, 58202

Sponsors and Collaborators

USDA Grand Forks Human Nutrition Research Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Gerald F Combs, PhD

USDA Grand Forks Human Nutrition Research Center

More Information

Publications:

Jackson MI, Combs GF Jr. Selenium and anticarcinogenesis: underlying mechanisms. Curr Opin Clin Nutr Metab Care. 2008 Nov;11(6):718-26.

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

Keywords provided by USDA Grand Forks Human Nutrition Research Center:

selenium

Study placed in the following topic categories:

Selenium
Antioxidants
Trace Elements
Micronutrients

Additional relevant MeSH terms:

Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs

Trace Elements
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009