Clinical trial NCT01289925: Effect of Selenium Intervention on Inflammation in Older Adults
Official title: Antioxidant Nutrient Inflammation Interventions in Older Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inflammation
Keywords: dietary supplement
selenium
healthy volunteer
Johns Hopkins
older
aging
geriatrics
baltimore
mineral
over 70
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2011-02-04
Enrollment: 182
Sex: ALL
Minimum age (years): 70
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
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.
timeFrame: 8 weeks
Secondary outcomes:
measure: 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.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jeremy D Walston, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walston J, Xue Q, Semba RD, Ferrucci L, Cappola AR, Ricks M, Guralnik J, Fried LP. Serum antioxidants, inflammation, and total mortality in older women. Am J Epidemiol. 2006 Jan 1;163(1):18-26. doi: 10.1093/aje/kwj007. Epub 2005 Nov 23.
citation: Semba RD, Patel KV, Ferrucci L, Sun K, Roy CN, Guralnik JM, Fried LP. Serum antioxidants and inflammation predict red cell distribution width in older women: the Women's Health and Aging Study I. Clin Nutr. 2010 Oct;29(5):600-4. doi: 10.1016/j.clnu.2010.03.001. Epub 2010 Mar 23.
citation: Ray AL, Semba RD, Walston J, Ferrucci L, Cappola AR, Ricks MO, Xue QL, Fried LP. Low serum selenium and total carotenoids predict mortality among older women living in the community: the women's health and aging studies. J Nutr. 2006 Jan;136(1):172-6. doi: 10.1093/jn/136.1.172.