Optimization of Selenoprotein P in Chinese Subjects - Tabular View

Tracking Information

First Received Date ^ICMJE

January 25, 2007

Last Updated Date

March 20, 2008

Start Date ^ICMJE

March 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Plasma selenoprotein P levels at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00428649 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Total plasma selenium concentrations at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
Plasma glutathione peroxidase activity at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
24hr urinary selenium excretion at 0, 20 and 40 weeks [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
Hair selenium levels at 0, 20 and 40 weeks [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Optimization of Selenoprotein P in Chinese Subjects

Official Title ^ICMJE

Optimization of Selenoprotein P in Chinese Subjects

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Selenium Deficiency

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Experimental: 20 µg selenium as selenomethionine
Experimental: 40 µg selenium as selenomethionine
Experimental: 60 µg selenium as selenomethionine
Experimental: 80 µg selenium as selenomethionine
Experimental: 100 µg selenium as selenomethionine
Experimental: 120 µg selenium as selenomethionine
Placebo Comparator: placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2008

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

17 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00428649

Responsible Party

Libby Salberg/Associate Director, Grants and Contracts Management, Vanderbilt University Medical Center

Study ID Numbers ^ICMJE

DK58763-opt

Study Sponsor ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Raymond F Burk, M.D.	Vanderbilt University
Study Director:	Yiming Xia, Ph.D.	Sichuan CDC, Chengdu

Information Provided By

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP