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

This study is currently recruiting participants.
Verified November 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01281995
First received: January 21, 2011
Last updated: March 14, 2014
Last verified: November 2013
  Purpose

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.

Condition Phase
Immunosuppression
Healthy
Healthy Subjects
Phase 1

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effects of Systemically Administered Hydrocortisone on the Human Immunome in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Effects of hydrocortisone on the human immune

Estimated Enrollment: 50
Study Start Date: January 2011
Detailed Description:

Corticosteroids have been in widespread therapeutic use as anti-inflammatory and immunomodulatory agents for decades, and there is a wealth of information on their immunosuppressive effects in animals and in human cells cultured in vitro. However, despite their ubiquitous clinical use, there is a paucity of information on the effects of corticosteroids administered to humans systemically, and no previous study has examined their effects on the human immunome.

Therefore the Center for Human Immunology, Autoimmunity, and Inflammatory Diseases proposes this protocol designed to obtain blood from healthy adult subjects at baseline, and then at various time points after administration of 250 mg and 50 mg of intravenous hydrocortisone. These samples will be used to perform a comprehensive and detailed analysis of the immune system in response to corticosteroid administration. To our knowledge, this protocol will be the first study to characterize the human cellular and molecular immune system parameters, or immunome, in healthy adult subjects after administration of corticosteroids. This information may be useful in understanding the mechanistic effects of this commonly prescribed class of medications in humans.

The primary objective is to perform laboratory studies to characterize the immune response in healthy adult volunteers after administration of moderate (250 mg) and low (50 mg) doses of the glucocorticoid hydrocortisone. Primary endpoint is the results of the research laboratory assessments. As samples will be stored indefinitely, the time frame for primary endpoint is indefinite.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Healthy volunteer (health status confirmed by History and Physical Exam and blood work)

Ages 18 years or older (no upper limit)

Must be willing to allow samples to undergo genetic studies

EXCLUSION CRITERIA:

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281995

Contacts
Contact: Paula Schum, R.N. (301) 402-3796 schump@mail.nih.gov
Contact: Shira Y Perl, M.D. (301) 594-0512 perls@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Shira Y Perl, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01281995     History of Changes
Other Study ID Numbers: 110092, 11-H-0092
Study First Received: January 21, 2011
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Biologic Samples
Hydrocortisone
Laboratory Research Specimens
Glucocorticoids
Immune Modulation
Healthy Volunteer
HV

Additional relevant MeSH terms:
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on April 21, 2014