- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01289925
Effect of Selenium Intervention on Inflammation in Older Adults
April 5, 2018 updated by: Johns Hopkins University
Antioxidant Nutrient Inflammation Interventions in Older Adults
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
182
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Johns Hopkins Bayview Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years to 110 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Sugar Pill
|
Placebo supplements in the same capsule mold as selenium and coated with the same inert coating. 1 tablet daily for 8 weeks.
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeremy D Walston, MD, Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2006
Primary Completion (Actual)
January 20, 2012
Study Completion (Actual)
January 20, 2012
Study Registration Dates
First Submitted
February 3, 2011
First Submitted That Met QC Criteria
February 3, 2011
First Posted (Estimate)
February 4, 2011
Study Record Updates
Last Update Posted (Actual)
April 9, 2018
Last Update Submitted That Met QC Criteria
April 5, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00002109
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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