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
  Purpose

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.


Condition Intervention
Inflammation
Dietary Supplement: Selenium
Other: Sugar Pill Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Antioxidant Nutrient Inflammation Interventions in Older Adults

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1200
Study Start Date: February 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Selenium 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.
Placebo Comparator: Sugar Pill 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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289925

Contacts
Contact: Jennifer M Hughes, PhD 410-550-2113 jhughe39@jhmi.edu
Contact: Leeondra M Thornton 410-550-9017 lthornt6@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Principal Investigator: Jeremy D Walston, MD         
Sub-Investigator: Richard Semba, MD MPH         
Sub-Investigator: Karen Bandeen Roche, PhD         
Sub-Investigator: Grace Cordts, MD MPH         
Sub-Investigator: Thomas Finucane, MD         
Sub-Investigator: Linda Fried, MD MPH         
Sub-Investigator: Sheldon Gottlieb, MD         
Sub-Investigator: Gary Noronha, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Jeremy D Walston, MD Johns Hopkins University
  More Information

Publications:
Responsible Party: Jeremy Walston MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01289925     History of Changes
Other Study ID Numbers: NA_00002109
Study First Received: February 3, 2011
Last Updated: February 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
dietary supplement
selenium
healthy volunteer
Johns Hopkins
older
aging
geriatrics
baltimore
mineral
over 70

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Selenium
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on July 22, 2014