Optimization of Selenoprotein P in Chinese Subjects

Selenium Deficiency Clinical Trial

Official title: Optimization of Selenoprotein P in Chinese Subjects

Status Completed

Clinical Trial 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

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Selenium Deficiency

• NCT number: NCT00428649
• Study type: Interventional
• Source: Vanderbilt University
• Status: Completed
• Phase: N/A
• Start date: March 2007
• Completion date: October 2008