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

USDA Grand Forks Human Nutrition Research Center

Status: Completed

Conditions: Nutritional Requirements

Treatments: Dietary Supplement: selenium as L-selenomethionine; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other U.S. Federal agency; NIH

Identifiers

NCT00803699

GFHNRC009

NCI Agreement#Y1-CN-2017-04

Details and patient eligibility

About

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

Full 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.

Enrollment: 262 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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262 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Capsule contains no selenium

Treatment:

Dietary Supplement: placebo

Selenium as L-selenomethionine

Active Comparator group

Description:

50, 100, or 200 micrograms of selenium

Treatment:

Dietary Supplement: selenium as L-selenomethionine