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Completed

NCT Number: NCT00428649

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

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Key information

Conditions

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sichuan Center for Disease Control and Prevention (Sichuan CDC)

Chengdu, Sichuan, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

20 µg selenium

Dietary Supplement

20 µg selenium as selenomethionine

40 µg selenium

Dietary Supplement

40 µg selenium as selenomethionine

60 µg selenium

Dietary Supplement

60 µg selenium as selenomethionine

80 µg selenium

Dietary Supplement

80 µg selenium as selenomethionine

100 µg selenium

Dietary Supplement

100 µg selenium as selenomethionine

120 µg selenium

Dietary Supplement

120 µg selenium as selenomethionine

Placebo

Dietary Supplement

placebo

Primary outcomes

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

    Time frame: 40 weeks

Secondary outcomes

  1. Total plasma selenium concentrations at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks

    Time frame: 40 weeks

  2. Plasma glutathione peroxidase activity at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks

    Time frame: 40 weeks

  3. 24hr urinary selenium excretion at 0, 20 and 40 weeks

    Time frame: 40 weeks

  4. Hair selenium levels at 0, 20 and 40 weeks

    Time frame: 40 weeks

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

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

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Jan 30, 2007
Registry last updated
Mar 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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