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Optimization of Selenoprotein P in Chinese Subjects

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ClinicalTrials.gov Identifier: NCT00428649
Recruitment Status : Completed
First Posted : January 30, 2007
Last Update Posted : March 7, 2012
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
RBurk, Vanderbilt University

January 25, 2007
January 30, 2007
March 7, 2012
March 2007
December 2007   (Final data collection date for primary outcome measure)
Plasma selenoprotein P levels at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks [ Time Frame: 40 weeks ]
Plasma selenoprotein P levels at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks
Complete list of historical versions of study NCT00428649 on ClinicalTrials.gov Archive Site
  • Total plasma selenium concentrations at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks [ Time Frame: 40 weeks ]
  • Plasma glutathione peroxidase activity at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks [ Time Frame: 40 weeks ]
  • 24hr urinary selenium excretion at 0, 20 and 40 weeks [ Time Frame: 40 weeks ]
  • Hair selenium levels at 0, 20 and 40 weeks [ Time Frame: 40 weeks ]
  • 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
Not Provided
Not Provided
 
Optimization of Selenoprotein P in Chinese Subjects
Optimization of Selenoprotein P in Chinese Subjects
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

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Selenium Deficiency
  • Dietary Supplement: 20 µg selenium
    20 µg selenium as selenomethionine
  • Dietary Supplement: 40 µg selenium
    40 µg selenium as selenomethionine
  • Dietary Supplement: 60 µg selenium
    60 µg selenium as selenomethionine
  • Dietary Supplement: 80 µg selenium
    80 µg selenium as selenomethionine
  • Dietary Supplement: 100 µg selenium
    100 µg selenium as selenomethionine
  • Dietary Supplement: 120 µg selenium
    120 µg selenium as selenomethionine
  • Dietary Supplement: placebo
    placebo
  • Experimental: 1
    20 µg selenium as selenomethionine
    Intervention: Dietary Supplement: 20 µg selenium
  • Experimental: 2
    40 µg selenium as selenomethionine
    Intervention: Dietary Supplement: 40 µg selenium
  • Experimental: 3
    60 µg selenium as selenomethionine
    Intervention: Dietary Supplement: 60 µg selenium
  • Experimental: 4
    80 µg selenium as selenomethionine
    Intervention: Dietary Supplement: 80 µg selenium
  • Experimental: 5
    100 µg selenium as selenomethionine
    Intervention: Dietary Supplement: 100 µg selenium
  • Experimental: 6
    120 µg selenium as selenomethionine
    Intervention: Dietary Supplement: 120 µg selenium
  • Placebo Comparator: 7
    placebo
    Intervention: Dietary Supplement: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
Same as current
October 2008
December 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
17 Years and older   (Child, Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00428649
DK58763-opt
R01DK058763 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
RBurk, Vanderbilt University
Vanderbilt University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Raymond F Burk, M.D. Vanderbilt University
Study Director: Yiming Xia, Ph.D. Sichuan CDC, Chengdu
Vanderbilt University
March 2012

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