| December 3, 2008 |
| December 4, 2008 |
| November 2005 |
| Evaluation of effectiveness of consuming oral doses of L-selenomethionine in raising plasma selenium concentrations [ Time Frame: Baseline, and after 3, 6, 9, and 12 months of supplementation ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00803699 on ClinicalTrials.gov Archive Site |
| 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. [ Time Frame: Baseline and after 12 months of supplementation ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels |
| Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels |
In this study, we will evaluate the effectiveness of several doses of oral selenomethionine in raising biomarkers of selenium status including plasma selenium concentrations. |
Results of studies with animal tumor models and human clinical trials suggest that the essential nutrient selenium can be anti-tumorigenic if consumed at levels greater than nutritional requirements. If it is possible to increase plasma selenium concentrations above 120 nanograms per milliliter with less than 200 micrograms of selenium daily, then it is possible that supplementation can be accomplished through the use of selenium-containing foods. |
| |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Parallel Assignment, Bio-availability Study |
| Nutritional Requirements |
- Dietary Supplement: placebo
- Dietary Supplement: selenium as L-selenomethionine
|
- Placebo Comparator: Capsule contains no selenium
- Active Comparator: 50, 100, or 200 micrograms of selenium
|
| Jackson MI, Combs GF Jr. Selenium and anticarcinogenesis: underlying mechanisms. Curr Opin Clin Nutr Metab Care. 2008 Nov;11(6):718-26. |
| |
| Completed |
| 262 |
| September 2007 |
| September 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- able to swallow capsules
- body mass index less than 40
Exclusion Criteria:
- 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
|
| Both |
| 18 Years and older |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
|
| |
| NCT00803699 |
| Geral F Combs, Jr, PhD Center Director, US Department of Agriculture |
| GFHNRC009, NCI Agreement#Y1-CN-2017-04 |
| USDA Grand Forks Human Nutrition Research Center |
| National Cancer Institute (NCI) |
| Principal Investigator: |
Gerald F Combs, PhD |
USDA Grand Forks Human Nutrition Research Center |
|
|
| USDA Grand Forks Human Nutrition Research Center |
| December 2008 |
