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NCT01289925 · ClinicalTrials.gov registry record · NA
Effect of Selenium Intervention on Inflammation in Older Adults
A NA study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- NA
- Development phase
- 182
- Enrollment target
NCT01289925: Clinical Trial NA study, sponsored by Johns Hopkins University.
NCT01289925 is a NA study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 182 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01289925, a NA study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- NA
- Development phase
- 182 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DIETARY_SUPPLEMENT Selenium
- OTHER Sugar Pill Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2006-02 |
| Est. Completion | 2012-01-20 |
| Phase | NA |
Why NCT01289925 stopped before completion
NCT01289925 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Selenium is the first listed.
NCT01289925 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01289925 about?
NCT01289925 is a clinical study titled "Effect of Selenium Intervention on Inflammation 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 in...
What is the current status of trial NCT01289925?
This trial is currently terminated. It is a NA study. The enrollment target is 182 participants. The study started on 2006-02. Estimated completion is 2012-01-20.
What interventions are being tested in trial NCT01289925?
The interventions under investigation include: Selenium (DIETARY_SUPPLEMENT), Sugar Pill Placebo (OTHER).
Who is sponsoring clinical trial NCT01289925?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01289925's enrollment target sits among peer trials
182 584th of 2000 higher than 1,415 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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