Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels
Information source: USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nutritional Requirements
Intervention: placebo (Dietary Supplement); selenium as L-selenomethionine (Dietary Supplement)
Phase: N/A
Status: Completed
Sponsored by: USDA Grand Forks Human Nutrition Research Center Official(s) and/or principal investigator(s):
Gerald F Combs, PhD, Principal Investigator, Affiliation: USDA Grand Forks Human Nutrition Research Center
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.
Clinical Details
Official title: Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Evaluation of effectiveness of consuming oral doses of L-selenomethionine in raising plasma selenium concentrations
Secondary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
USDA Grand Forks Human Nutrition Research Center, Grand Forks, North Dakota 58202, United States
Additional Information
Related publications: 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.
Starting date: November 2005
Last updated: December 4, 2008
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