Optimization of Selenoprotein P in Chinese Subjects

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
RBurk, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00428649
First received: January 25, 2007
Last updated: March 6, 2012
Last verified: March 2012
  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:


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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on September 22, 2014