Optimization of Selenoprotein P in Chinese Subjects

Vanderbilt University

Status: Completed

Conditions: Selenium Deficiency

Treatments: Dietary Supplement: 100 µg selenium; Dietary Supplement: 80 µg selenium; Dietary Supplement: 120 µg selenium; Dietary Supplement: 40 µg selenium; Dietary Supplement: placebo; Dietary Supplement: 20 µg selenium; Dietary Supplement: 60 µg selenium

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00428649

DK58763-opt

R01DK058763 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 17+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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98 participants in 7 patient groups, including a placebo group

1

Experimental group

Description:

20 µg selenium as selenomethionine

Treatment:

Dietary Supplement: 20 µg selenium

2

Experimental group

Description:

40 µg selenium as selenomethionine

Treatment:

Dietary Supplement: 40 µg selenium

3

Experimental group

Description:

60 µg selenium as selenomethionine

Treatment:

Dietary Supplement: 60 µg selenium

4

Experimental group

Description:

80 µg selenium as selenomethionine

Treatment:

Dietary Supplement: 80 µg selenium

5

Experimental group

Description:

100 µg selenium as selenomethionine

Treatment:

Dietary Supplement: 100 µg selenium

6

Experimental group

Description:

120 µg selenium as selenomethionine

Treatment:

Dietary Supplement: 120 µg selenium

7

Placebo Comparator group

Description:

placebo

Treatment:

Dietary Supplement: placebo