Optimization of Selenoprotein P in Chinese Subjects

Selenium Deficiency Clinical Trial

Official title:

Optimization of Selenoprotein P in Chinese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00428649
• Other study ID #: DK58763-opt
• Secondary ID: R01DK058763
• Status: Completed
• Phase: N/A
• First received: January 25, 2007
• Last updated: March 6, 2012
• Start date: March 2007
• Est. completion date: October 2008

Study information

• Verified date: March 2012
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: October 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• aged 17 years or older

• healthy

• 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

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

Intervention

Dietary Supplement:
• 20 µg selenium
20 µg selenium as selenomethionine
• 40 µg selenium
40 µg selenium as selenomethionine
• 60 µg selenium
60 µg selenium as selenomethionine
• 80 µg selenium
80 µg selenium as selenomethionine
• 100 µg selenium
100 µg selenium as selenomethionine
• 120 µg selenium
120 µg selenium as selenomethionine
• placebo
placebo

Locations

Country	Name	City	State
China	Sichuan Center for Disease Control and Prevention (Sichuan CDC)	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

China, 

References & Publications (2)

Casey CE, Guthrie BE, Friend GM, Robinson MF. Selenium in human tissues from New Zealand. Arch Environ Health. 1982 May-Jun;37(3):133-5. — View Citation

Xia Y, Hill KE, Byrne DW, Xu J, Burk RF. Effectiveness of selenium supplements in a low-selenium area of China. Am J Clin Nutr. 2005 Apr;81(4):829-34. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma selenoprotein P levels at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks		40 weeks	No
Secondary	Total plasma selenium concentrations at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks		40 weeks	No
Secondary	Plasma glutathione peroxidase activity at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks		40 weeks	No
Secondary	24hr urinary selenium excretion at 0, 20 and 40 weeks		40 weeks	No
Secondary	Hair selenium levels at 0, 20 and 40 weeks		40 weeks	No