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Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels (LoDoSe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00803699
Recruitment Status : Completed
First Posted : December 5, 2008
Last Update Posted : May 29, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
USDA Grand Forks Human Nutrition Research Center

Tracking Information
First Submitted Date  ICMJE December 3, 2008
First Posted Date  ICMJE December 5, 2008
Last Update Posted Date May 29, 2018
Study Start Date  ICMJE November 2005
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2008)		 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2008)		 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels
Official Title  ICMJE Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Nutritional Requirements
Intervention  ICMJE
  • Dietary Supplement: placebo
    daily placebo capsules for 12 months
  • Dietary Supplement: selenium as L-selenomethionine
    daily capsules of 50, 100, or 200 micrograms of L-selenomethionine for 12 months
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Capsule contains no selenium
    Intervention: Dietary Supplement: placebo
  • Active Comparator: Selenium as L-selenomethionine
    50, 100, or 200 micrograms of selenium
    Intervention: Dietary Supplement: selenium as L-selenomethionine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2008)		 262
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00803699
Other Study ID Numbers  ICMJE GFHNRC009
NCI Agreement#Y1-CN-2017-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party USDA Grand Forks Human Nutrition Research Center
Original Responsible Party Geral F Combs, Jr, PhD Center Director, US Department of Agriculture
Current Study Sponsor  ICMJE USDA Grand Forks Human Nutrition Research Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Gerald F Combs, PhD USDA Grand Forks Human Nutrition Research Center
PRS Account USDA Grand Forks Human Nutrition Research Center
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP