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Effects of Systemically Administered Hydrocortisone on the Immune System in Healthy Volunteers
NCT01281995 · View on ClinicalTrials.gov ↗
Study Summary
Background: \- Corticosteroids have been used to treat inflammation and immune system diseases for decades. However, despite their widespread use, there is little information on the specifics of how corticosteroids affect the immune system in humans. The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases is interested in studying how the steroid hormone hydrocortisone affects the immune system in healthy volunteers, and in doing so to understand how hydrocortisone given at different doses works in treating many immune and inflammatory conditions. Objectives: \- To evaluate the effects of hydrocortisone on the immune and inflammatory responses of healthy volunteers over the short and intermediate term (up to 28 days after administration). Eligibility: \- Healthy volunteers at least 18 years of age. Design: * Participants will be screened with a full medical history and physical examination, and blood and urine tests. At this visit, participants will be separated into two groups, with each group scheduled to receive a different amount of hydrocortisone during the study visit. * One week before the study visit, participants will provide a blood sample for baseline testing. * Participants will be admitted for a 24-hour inpatient stay that will involve frequent blood draws. Between blood draws, participants will be able to work, watch TV, walk around, and so on, and will be provided with regular meals. * Blood will be drawn 1 hour before the infusion of hydrocortisone. Participants will be divided into two further sets of groups with different blood draw schedules: * Groups 1 (lower dose) and 2 (higher dose) will have blood draws 1, 4, 8, 12, and 24 hours after the hydrocortisone infusion. * Groups 3 (lower dose) and 4 (higher dose) will have multiple blood draws over 24 hours, with timing based on data from the previous groups blood test results. * Participants will provide additional blood samples 7 and 28 days after the in-patient visit....
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2011-01-21 |
| Est. Completion | 2018-08-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01281995
The ClinicalTrials.gov registry entry for NCT01281995 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 381 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Healthy appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01281995 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01281995 about?
NCT01281995 is a clinical study titled "Effects of Systemically Administered Hydrocortisone on the Immune System in Healthy Volunteers". Background: \- Corticosteroids have been used to treat inflammation and immune system diseases for decades. However, despite their widespread use, there is little information on the specifics of how corticosteroids affect the immune system in humans. The Center for Human Immunology, Autoimmunity, a...
What is the current status of trial NCT01281995?
This trial is currently completed. The enrollment target is 22 participants. The study started on 2011-01-21. Estimated completion is 2018-08-30.
What conditions does trial NCT01281995 study?
This clinical trial studies the following conditions: Healthy, Healthy Subjects, Immunosuppression. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01281995?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 381 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01281995 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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