Effect of Selenium Intervention on Inflammation in Older Adults
|ClinicalTrials.gov Identifier: NCT01289925|
Recruitment Status : Unknown
Verified February 2011 by Johns Hopkins University.
Recruitment status was: Recruiting
First Posted : February 4, 2011
Last Update Posted : February 4, 2011
|Condition or disease||Intervention/treatment|
|Inflammation||Dietary Supplement: Selenium Other: Sugar Pill Placebo|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Antioxidant Nutrient Inflammation Interventions in Older Adults|
|Study Start Date :||February 2006|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Dietary Supplement: Selenium
200 micrograms of selenium (in the form of selenium methionine) in tablet form taken orally daily for 8 weeks. Capsule molds with inert coating.
|Placebo Comparator: Sugar Pill||
Other: Sugar Pill Placebo
Placebo supplements in the same capsule mold as selenium and coated with the same inert coating. 1 tablet daily for 8 weeks.
- The effects of oral selenium supplementation on the inflammatory response in older adults with an increased IL-6 level and low normal selenium levels over an 8 week intervention period. [ Time Frame: 8 weeks ]Serum Interleukin 6 (IL6)will be measured at baseline and every 2 weeks for the 8 weeks of the study using a standard, commercially available ELISA kit. Serum Selenium levels will also be measured at baseline and every 2 weeks for 8 weeks. The investigators hypothesize that as serum selenium levels increase with supplementation there will be a statistically significant decrease in serum IL6. IL6 levels should remain unchanged over 8 weeks in those taking the placebo.
- The effects of selenium supplementation on the activity of the selenium- dependent antioxidant enzyme glutathione peroxidase, and on altered protein production in older adults with increased serum IL-6 and low normal levels of selenium. [ Time Frame: 8 weeks ]Glutathione peroxidase will be measured at baseline and at week 8. Glucose, Vitamin B-12, folate, methionine, and albumin will be measured in serum drawn at baseline and every 2 weeks for the 8 weeks of the study. the investigators hypothesize that levels of glutathione peroxidase and proteins may change significantly in participants taking selenium. There should be no significant changes in these parameters in those taking the placebo.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01289925
|Contact: Jennifer M Hughes, PhDemail@example.com|
|Contact: Leeondra M Thorntonfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Bayview Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator: Jeremy D Walston, MD|
|Sub-Investigator: Richard Semba, MD MPH|
|Sub-Investigator: Karen Bandeen Roche, PhD|
|Sub-Investigator: Grace Cordts, MD MPH|
|Sub-Investigator: Thomas Finucane, MD|
|Sub-Investigator: Linda Fried, MD MPH|
|Sub-Investigator: Sheldon Gottlieb, MD|
|Sub-Investigator: Gary Noronha, MD|
|Principal Investigator:||Jeremy D Walston, MD||Johns Hopkins University|