Effect of Selenium Intervention on Inflammation in Older Adults

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01289925
First received: February 3, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted

February 3, 2011
February 3, 2011
February 2006
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
Effect of Selenium Intervention on Inflammation in Older Adults
Antioxidant Nutrient Inflammation Interventions in Older Adults

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Inflammation
  • 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.
  • 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.
  • Experimental: Selenium
    Intervention: Dietary Supplement: Selenium
  • Placebo Comparator: Sugar Pill
    Intervention: Other: Sugar Pill Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 70 years of age or older
  • Able to provide written informed consent for screening and participation in the study

Exclusion Criteria:

  • Taking a multi-vitamin containing 60 ug or more of Selenium more than once a week
  • Have evidence of an active, untreated, acute inflammatory disease state such as rheumatoid arthritis, gout, or malignancy
  • Taking any corticosteroids or the medications prednisone or methotrexate
Both
70 Years and older
Yes
Contact: Jennifer M Hughes, PhD 410-550-2113 jhughe39@jhmi.edu
Contact: Leeondra M Thornton 410-550-9017 lthornt6@jhmi.edu
United States
 
NCT01289925
NA_00002109
Yes
Jeremy Walston MD, Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Jeremy D Walston, MD Johns Hopkins University
Johns Hopkins University
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP