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Clinical Trials/NCT00428649
NCT00428649CompletedNot Applicable

Optimization of Selenoprotein P in Chinese Subjects

Vanderbilt University1 site in 1 country98 target enrollmentStarted: March 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
98
Locations
1
Primary Endpoint
Plasma selenoprotein P levels at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks

Study Overview

Brief Summary

The purpose of this study is to determine the amount of selenium as selenomethionine that is required to optimize selenoprotein P in selenium-deficient Chinese subjects

Detailed Description

Selenium is an essential nutrient. The Recommended Dietary Allowance (RDA) for selenium is considered to be the amount required to optimize plasma selenoproteins. There are two selenoproteins present in the plasma: selenoprotein P (Se-P) and glutathione peroxidase 3 (GPX-3). Although the amount of selenium required to optimize GPX-3 has been determined, the amount required to optimize Se-P in the plasma remains unknown. We aim to determine this amount by supplementing selenium deficient subjects with varying amounts of selenium as selenomethionine.

The study will take place in Mianning County, China, where selenium status is low. Approximately 150 people will be screened for eligibility to participate in this study. 98 subjects will be enrolled. Background information obtained from each participant will be: age, height, weight and smoking status.

Subjects will be randomized to a selenium supplement group. The selenium supplement will contain either 0, 20, 40, 60, 80, 100, or 120 µg of selenium as selenomethionine. A CDC worker will visit each participant daily to give them their selenium supplement. The CDC worker will watch them take their supplement and will ask if they have any unanticipated problems. Blood samples of 20 ml will be obtained at weeks 0, 4, 8, 12, 16, 20, 24, 32, and 40. Hair samples and 24-hr urine collections will be obtained at 0, 20 and 40 weeks. The total study duration is 40 weeks.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
17 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • aged 17 years or older
  • resident of Mianning County for at least 1 year
  • hematocrit (PCV) of 30 or greater

Exclusion Criteria

  • subject has taken selenium supplements within the year prior to study
  • subject plans to relocate during study

Outcomes

Primary Outcomes

Plasma selenoprotein P levels at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks

Time Frame: 40 weeks

Secondary Outcomes

  • Total plasma selenium concentrations at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks(40 weeks)
  • Plasma glutathione peroxidase activity at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks(40 weeks)
  • 24hr urinary selenium excretion at 0, 20 and 40 weeks(40 weeks)
  • Hair selenium levels at 0, 20 and 40 weeks(40 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

RBurk

M.D.

Vanderbilt University

Study Sites (1)

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