Effect of Selenium Intervention on Inflammation in Older Adults

Not Applicable

Terminated

• Conditions: Inflammation
• Interventions: Dietary Supplement: Selenium; Other: Sugar Pill Placebo

• Registration Number: NCT01289925
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2011-02-03
• Study First Submitted QC: 2011-02-03
• Study First Posted: 2011-02-04
• Primary Completion: 2012-01-20
• Study Completion: 2012-01-20
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 182

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Selenium	Selenium	-
Sugar Pill	Sugar Pill Placebo	-

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States