Effect of Selenium Intervention on Inflammation in Older Adults

NCT01289925 | Terminated DMC

• 1 other identifier: NA_00002109
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation

Keywords

dietary supplement; selenium; healthy volunteer; Johns Hopkins; older; aging; geriatrics; baltimore; mineral; over 70

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  8 weeks

Secondary Outcomes (1)

• 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 Arms (2)

Selenium

EXPERIMENTAL

Dietary Supplement: Selenium

Sugar Pill

PLACEBO COMPARATOR

Other: Sugar Pill Placebo

Interventions

Selenium DIETARY_SUPPLEMENT

200 micrograms of selenium (in the form of selenium methionine) in tablet form taken orally daily for 8 weeks. Capsule molds with inert coating.

Selenium

Sugar Pill Placebo OTHER

Placebo supplements in the same capsule mold as selenium and coated with the same inert coating. 1 tablet daily for 8 weeks.

Sugar Pill

Eligibility Criteria

• Age: 70 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

• 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.

  PMID: 16306311 BACKGROUND

• 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.

  PMID: 20334961 BACKGROUND

• 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.

  PMID: 16365078 BACKGROUND

MeSH Terms

Conditions

Inflammation; Calcinosis

Interventions

Selenium; Sugars

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals; Carbohydrates

Study Officials

• Jeremy D Walston, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 4, 2011
• Study Start: February 1, 2006
• Primary Completion: January 20, 2012
• Study Completion: January 20, 2012
• Last Updated: April 9, 2018

Record last verified: 2018-04

Locations

US (1)