Optimization of Selenoprotein P in Chinese Subjects - Full Text View

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00428649

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:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Optimization of Selenoprotein P in Chinese Subjects

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets

Drug Information available for: Selenium

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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 ]

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

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

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

Locations

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

Sponsors and Collaborators

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.

Responsible Party:	Vanderbilt University Medical Center ( Libby Salberg/Associate Director, Grants and Contracts Management )
Study ID Numbers:	DK58763-opt
Study First Received:	January 25, 2007
Last Updated:	March 20, 2008
ClinicalTrials.gov Identifier:	NCT00428649 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Selenium supplements
Selenoprotein P
Optimization

Additional relevant MeSH terms:

Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs

Trace Elements
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 05, 2009