Optimization of Selenoprotein P in Chinese Subjects - Full Text View

Purpose

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

Condition	Intervention
Selenium Deficiency	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 Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Optimization of Selenoprotein P in Chinese Subjects

Resource links provided by NLM:

Drug Information available for: Selenomethionine

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]


Enrollment:	98
Study Start Date:	March 2007
Study Completion Date:	October 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 20 µg selenium as selenomethionine	Dietary Supplement: 20 µg selenium 20 µg selenium as selenomethionine
Experimental: 2 40 µg selenium as selenomethionine	Dietary Supplement: 40 µg selenium 40 µg selenium as selenomethionine
Experimental: 3 60 µg selenium as selenomethionine	Dietary Supplement: 60 µg selenium 60 µg selenium as selenomethionine
Experimental: 4 80 µg selenium as selenomethionine	Dietary Supplement: 80 µg selenium 80 µg selenium as selenomethionine
Experimental: 5 100 µg selenium as selenomethionine	Dietary Supplement: 100 µg selenium 100 µg selenium as selenomethionine
Experimental: 6 120 µg selenium as selenomethionine	Dietary Supplement: 120 µg selenium 120 µg selenium as selenomethionine
Placebo Comparator: 7 placebo	Dietary Supplement: placebo placebo

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.

Eligibility


Ages Eligible for Study:	17 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428649

Locations


China, Sichuan
Sichuan Center for Disease Control and Prevention (Sichuan CDC)
Chengdu, Sichuan, China

Sponsors and Collaborators

Vanderbilt University

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

Investigators


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

More Information

Publications:

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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Xia Y, Hill KE, Li P, Xu J, Zhou D, Motley AK, Wang L, Byrne DW, Burk RF. Optimization of selenoprotein P and other plasma selenium biomarkers for the assessment of the selenium nutritional requirement: a placebo-controlled, double-blind study of selenomethionine supplementation in selenium-deficient Chinese subjects. Am J Clin Nutr. 2010 Sep;92(3):525-31. doi: 10.3945/ajcn.2010.29642. Epub 2010 Jun 23.


Responsible Party:	RBurk, M.D., Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00428649 History of Changes
Other Study ID Numbers:	DK58763-opt, R01DK058763
Study First Received:	January 25, 2007
Last Updated:	March 6, 2012
Health Authority:	United States: Federal Government

Keywords provided by Vanderbilt University:


Selenium supplements Selenoprotein P Optimization

Additional relevant MeSH terms:


Selenium Antioxidants Growth Substances Micronutrients Molecular Mechanisms of Pharmacological Action	Pharmacologic Actions Physiological Effects of Drugs Protective Agents Trace Elements

ClinicalTrials.gov processed this record on February 25, 2015