Effects of Systemically Administered Hydrocortisone on the Immune System in Healthy Volunteers

Completed

Conditions studied: Immunosuppression, Healthy, Healthy Subjects

In brief

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....

Key facts

Study ID: NCT01281995
Run by: National Heart, Lung, and Blood Institute (NHLBI)
People needed: 22
Starts: 2011-01-21
Expected to finish: 2018-08-30
Last updated by the study team: 2018-09-04

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

Patients with diseases with an inflammatory or immune component
Patients who have irregular circadian rhythms, i.e. those who are blind or work night shifts
Patients with active infections requiring systemic antibiotic therapy
Use of immune modifying medications, i.e. NSAIDs (such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), ketorolac (Toradol) within the past month
Systemic fungal, viral, or mycobacterial infections
Persons who are alcoholic or abusers of illicit substances
Abnormal fasting glucose >100mg/dL
Female subjects may not be pregnant or lactating due to possible side effects of use of hydrocortisone in a non-benefit study
Liver function tests (AST, ALT, total bilirubin, alkaline phosphatase) above the normal laboratory reference range
Other contraindications to corticosteroids (i.e. gastrointestinal ulceration, Cushing s syndrome, congestive heart failure, uncontrolled hypertension, glaucoma, osteoporosis, or known hypersensitivity to corticosteroids)
Corticosteroid use within the last six months prior to enrollment, including topical, intra-articular or intramuscular injections, or inhaled administration
Prior use of systemically administered corticosteroids for >6 months duration
Use of azole medications or chronic opiates
Patients with psychiatric diagnoses or symptoms, to include hypomania, bipolar disorder, major depression, or dysthymia
Patients with a body mass index greater than 30
Subjects unable to comprehend the investigational nature of the study or those who are unable or unwilling to sign the consent

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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