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OpenTrials
Completed

NCT Number: NCT00803699

Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels

In this study, we will evaluate the effectiveness of several doses of oral selenomethionine in raising biomarkers of selenium status including plasma selenium concentrations.

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Key information

Conditions

Nutritional Requirements

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

daily placebo capsules for 12 months

selenium as L-selenomethionine

Dietary Supplement

daily capsules of 50, 100, or 200 micrograms of L-selenomethionine for 12 months

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

USDA Grand Forks Human Nutrition Research Center

Fed

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: LoDoSe

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Dec 5, 2008
Registry last updated
May 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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