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Optimization of Selenoprotein P in Chinese Subjects

Optimization of Selenoprotein P in Chinese Subjects

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00428649
Enrollment
98
Registered
2007-01-30
Start date
2007-03-31
Completion date
2008-10-31
Last updated
2012-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Selenium Deficiency

Keywords

Selenium supplements, Selenoprotein P, Optimization

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENT20 µg selenium

20 µg selenium as selenomethionine

DIETARY_SUPPLEMENT40 µg selenium

40 µg selenium as selenomethionine

DIETARY_SUPPLEMENT60 µg selenium

60 µg selenium as selenomethionine

DIETARY_SUPPLEMENT80 µg selenium

80 µg selenium as selenomethionine

DIETARY_SUPPLEMENT100 µg selenium

100 µg selenium as selenomethionine

DIETARY_SUPPLEMENT120 µg selenium

120 µg selenium as selenomethionine

DIETARY_SUPPLEMENTplacebo

placebo

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Plasma selenoprotein P levels at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks40 weeks

Secondary

MeasureTime frame
Total plasma selenium concentrations at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks40 weeks
Plasma glutathione peroxidase activity at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks40 weeks
24hr urinary selenium excretion at 0, 20 and 40 weeks40 weeks
Hair selenium levels at 0, 20 and 40 weeks40 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026