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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT00803699
First received: December 3, 2008
Last updated: December 4, 2008
Last verified: December 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels

Resource links provided by NLM:


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 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Geral F Combs, Jr, PhD Center Director, US Department of Agriculture
ClinicalTrials.gov Identifier: NCT00803699     History of Changes
Other Study ID Numbers: GFHNRC009, NCI Agreement#Y1-CN-2017-04
Study First Received: December 3, 2008
Last Updated: December 4, 2008
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by USDA Grand Forks Human Nutrition Research Center:
selenium

Additional relevant MeSH terms:
Selenium
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Trace Elements

ClinicalTrials.gov processed this record on October 29, 2014