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Effect of Selenium Intervention on Inflammation in Older Adults

Johns Hopkins University logo

Johns Hopkins University

Status

Terminated

Conditions

Inflammation

Treatments

Dietary Supplement: Selenium
Other: Sugar Pill Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01289925
NA_00002109

Details and patient eligibility

About

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.

Enrollment

182 patients

Sex

All

Ages

70 to 110 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

182 participants in 2 patient groups, including a placebo group

Selenium
Experimental group
Treatment:
Dietary Supplement: Selenium
Sugar Pill
Placebo Comparator group
Treatment:
Other: Sugar Pill Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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