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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nutritional Requirements Dietary Supplement: placebo Dietary Supplement: selenium as L-selenomethionine Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels
Study Start Date : November 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Capsule contains no selenium
 Dietary Supplement: placebo
daily placebo capsules for 12 months
Active Comparator: Selenium as L-selenomethionine
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803699


Locations
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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
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Principal Investigator: Gerald F Combs, PhD USDA Grand Forks Human Nutrition Research Center
More Information
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Publications:

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Responsible Party: USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT00803699    
Other Study ID Numbers: GFHNRC009
NCI Agreement#Y1-CN-2017-04
First Posted: December 5, 2008    Key Record Dates
Last Update Posted: May 29, 2018
Last Verified: May 2018
Keywords provided by USDA Grand Forks Human Nutrition Research Center:
selenium
Additional relevant MeSH terms:
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Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
 Physiological Effects of Drugs
Trace Elements
Micronutrients