Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00803699

Acronym

LoDoSe

Enrollment

262

Registered

2008-12-05

Start date

2005-11-30

Completion date

2007-09-30

Last updated

2018-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional Requirements

Keywords

selenium

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.

Interventions

DIETARY_SUPPLEMENTplacebo

daily placebo capsules for 12 months

DIETARY_SUPPLEMENTselenium as L-selenomethionine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Evaluation of effectiveness of consuming oral doses of L-selenomethionine in raising plasma selenium concentrations	Baseline, and after 3, 6, 9, and 12 months of supplementation

Secondary

Measure	Time frame
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.	Baseline and after 12 months of supplementation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026