NCT00428649

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 30, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

9 months

First QC Date

January 25, 2007

Last Update Submit

March 6, 2012

Conditions

Selenium Deficiency

Keywords

Selenium supplementsSelenoprotein POptimization

Outcome Measures

Primary Outcomes (1)

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

    40 weeks

Secondary Outcomes (4)

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

    40 weeks

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

    40 weeks

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

    40 weeks

  • Hair selenium levels at 0, 20 and 40 weeks

    40 weeks

Study Arms (7)

1

EXPERIMENTAL

20 µg selenium as selenomethionine

Dietary Supplement: 20 µg selenium

2

EXPERIMENTAL

40 µg selenium as selenomethionine

Dietary Supplement: 40 µg selenium

3

EXPERIMENTAL

60 µg selenium as selenomethionine

Dietary Supplement: 60 µg selenium

4

EXPERIMENTAL

80 µg selenium as selenomethionine

Dietary Supplement: 80 µg selenium

5

EXPERIMENTAL

100 µg selenium as selenomethionine

Dietary Supplement: 100 µg selenium

6

EXPERIMENTAL

120 µg selenium as selenomethionine

Dietary Supplement: 120 µg selenium

7

PLACEBO COMPARATOR

placebo

Dietary Supplement: placebo

Interventions

20 µg seleniumDIETARY_SUPPLEMENT

20 µg selenium as selenomethionine

1
40 µg seleniumDIETARY_SUPPLEMENT

40 µg selenium as selenomethionine

2
60 µg seleniumDIETARY_SUPPLEMENT

60 µg selenium as selenomethionine

3
80 µg seleniumDIETARY_SUPPLEMENT

80 µg selenium as selenomethionine

4
100 µg seleniumDIETARY_SUPPLEMENT

100 µg selenium as selenomethionine

5
120 µg seleniumDIETARY_SUPPLEMENT

120 µg selenium as selenomethionine

6
placeboDIETARY_SUPPLEMENT

placebo

7

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • aged 17 years or older
  • healthy
  • resident of Mianning County for at least 1 year
  • hematocrit (PCV) of 30 or greater

You may not qualify if:

  • subject has taken selenium supplements within the year prior to study
  • subject plans to relocate during study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Center for Disease Control and Prevention (Sichuan CDC)

Chengdu, Sichuan, China

Location

Related Publications (3)

  • Xia Y, Hill KE, Byrne DW, Xu J, Burk RF. Effectiveness of selenium supplements in a low-selenium area of China. Am J Clin Nutr. 2005 Apr;81(4):829-34. doi: 10.1093/ajcn/81.4.829.

    PMID: 15817859BACKGROUND

  • Casey CE, Guthrie BE, Friend GM, Robinson MF. Selenium in human tissues from New Zealand. Arch Environ Health. 1982 May-Jun;37(3):133-5. doi: 10.1080/00039896.1982.10667551.

    PMID: 7092329BACKGROUND

  • Xia Y, Hill KE, Li P, Xu J, Zhou D, Motley AK, Wang L, Byrne DW, Burk RF. Optimization of selenoprotein P and other plasma selenium biomarkers for the assessment of the selenium nutritional requirement: a placebo-controlled, double-blind study of selenomethionine supplementation in selenium-deficient Chinese subjects. Am J Clin Nutr. 2010 Sep;92(3):525-31. doi: 10.3945/ajcn.2010.29642. Epub 2010 Jun 23.

    PMID: 20573787DERIVED

MeSH Terms

Interventions

Selenium

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMinerals

Study Officials

  • Raymond F Burk, M.D.

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

  • Yiming Xia, Ph.D.

    Sichuan CDC, Chengdu

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 30, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2007

Study Completion

October 1, 2008

Last Updated

March 7, 2012

Record last verified: 2012-03

Locations

CN(1)