Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels
LoDoSe
2 other identifiers
interventional
262
1 country
1
Brief Summary
In this study, we will evaluate the effectiveness of several doses of oral selenomethionine in raising biomarkers of selenium status including plasma selenium concentrations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 3, 2008
CompletedFirst Posted
Study publicly available on registry
December 5, 2008
CompletedMay 29, 2018
May 1, 2018
1.8 years
December 3, 2008
May 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of effectiveness of consuming oral doses of L-selenomethionine in raising plasma selenium concentrations
Baseline, and after 3, 6, 9, and 12 months of supplementation
Secondary Outcomes (1)
Biomarkers of selenium status will be determined in urine, buccal cells, and plasma. White blood cells will be analyzed to identify DNA damage, reflecting the degree of oxidative damage and evaluate the status of antioxidant repair mechanisms.
Baseline and after 12 months of supplementation
Study Arms (2)
Placebo
PLACEBO COMPARATORCapsule contains no selenium
Selenium as L-selenomethionine
ACTIVE COMPARATOR50, 100, or 200 micrograms of selenium
Interventions
daily capsules of 50, 100, or 200 micrograms of L-selenomethionine for 12 months
Eligibility Criteria
You may qualify if:
- able to swallow capsules
- body mass index less than 40
You may not qualify if:
- Pregnancy
- Chronic liver or kidney disease
- taking medication that might affect liver and/or kidney
- blood pressure 140/90 or higher
- already taking more than 50 micrograms of selenium
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58202, United States
Related Publications (1)
Jackson MI, Combs GF Jr. Selenium and anticarcinogenesis: underlying mechanisms. Curr Opin Clin Nutr Metab Care. 2008 Nov;11(6):718-26. doi: 10.1097/MCO.0b013e3283139674.
PMID: 18827575BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerald F Combs, PhD
USDA Grand Forks Human Nutrition Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2008
First Posted
December 5, 2008
Study Start
November 1, 2005
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
May 29, 2018
Record last verified: 2018-05