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Clinical Trials/NCT01289925
NCT01289925
Terminated
Not Applicable

Antioxidant Nutrient Inflammation Interventions in Older Adults

Johns Hopkins University1 site in 1 country182 target enrollmentFebruary 2006
ConditionsInflammation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inflammation
Sponsor
Johns Hopkins University
Enrollment
182
Locations
1
Primary Endpoint
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.
Status
Terminated
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2006
End Date
January 20, 2012
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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.(8 weeks)

Study Sites (1)

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