Effect of Selenium Intervention on Inflammation in Older Adults
Recruitment status was Recruiting
Serum levels of inflammatory mediators increase with age and are strongly associated with the most common and the most devastating health conditions found in older adults including frailty, chronic disease, disability and increased mortality. Even though the processes that contribute to increased inflammatory mediators are likely not completely reversible in older adults, the development of a safe and effective intervention that modulates inappropriate inflammatory responses could be a very important component of prevention against frailty and other adverse health outcomes. As part of an ongoing effort to identify molecular and physiologic triggers of inflammation in older adults, the investigators recently identified a highly significant inverse relationship between the anti-oxidant micronutrient selenium and the inflammatory mediator IL-6, as well as a significant relationship between selenium and all cause mortality in a population of community dwelling older women with selenium levels well below the mean for the overall American population. Based on our findings in older adults and on data from other studies that suggest that selenium interventions are effective in targeted populations with inflammatory conditions, the investigators hypothesize that selenium supplementation targeted to a population of older adults with increased inflammatory markers and low normal selenium levels will in the short term reduce inflammation as measured by serum IL-6, and in the long term will reduce the incidence and prevalence of inflammation associated poor health outcomes of frailty, disability, and mortality in vulnerable older adults.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
|Official Title:||Antioxidant Nutrient Inflammation Interventions in Older Adults|
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2006|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289925
|Contact: Jennifer M Hughes, PhDfirstname.lastname@example.org|
|Contact: Leeondra M Thorntonemail@example.com|
|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|