Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Nutritional Requirements

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Capsule contains no selenium

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

daily placebo capsules for 12 months

Selenium as L-selenomethionine

50, 100, or 200 micrograms of selenium

Group Type ACTIVE_COMPARATOR

selenium as L-selenomethionine

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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placebo

daily placebo capsules for 12 months

Intervention Type DIETARY_SUPPLEMENT

selenium as L-selenomethionine

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes