Patient Self-administration of Cortisol for Cortisol-responding Disorders in Men and Women Over the Age of 17

• ClinicalTrials.gov Identifier: NCT03558971
• Recruitment Status: Completed
• First Posted: June 15, 2018
• Last Update Posted: June 15, 2018
• Sponsor: Helen Foundation
• Information provided by (Responsible Party): Helen Foundation

Study Description

Brief Summary:

Participants diagnosed as having fibromyalgia, osteoarthritis, and rheumatoid arthritis are to be brought to a minimum symptom state using a 3-week period during which they are to ingest modest doses of cortisol tablets with weekly lowered tapered doses. Thereafter, the participants are to be taught to self-administer cortisol tablets on the as-needed basis to maintain the minimum symptom state. For this, they are to ingest a smaller-dosage, 5-day tapered regimen of cortisol tablets to quench each reoccurring exacerbation of the disease at its earliest stage. Participants are limited to using less than the safe use limit of cortisol per month and are required to include a minimum of 10 days per month during which no cortisol was ingested.

Condition or disease	Intervention/treatment	Phase
Rheumatic Diseases	Drug: Cortisol	Phase 4

Detailed Description:

OBJECTIVE: To define why and demonstrate how patient self-administration of cortisol with stress management eliminates chronic inflammation pain within fibromyalgia, osteoarthritis, and rheumatoid arthritis.

METHODS: One thousand seventeen hundred and twenty (1,720) participants with chronic inflammation-containing diseases, were brought to a minimum symptom state using daily-administered cortisol tablets. Thereafter, participants used 5-day, small-dosage cortisol regimens to quench subsequent disorder exacerbations to maintain the minimum symptom state. Stressors as emotional traumas, infections, allergies, and injuries were minimized to reduce cortisol consumption and participant discomfort. This protocol is compliant with current United States Food and Drug Administration recommendations for cortisol use applied to corticosteroid-responding disorders.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2430 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All participants follow the same treatment protocol: First, the participants ingest a defined dosage, 3-week treatment of cortisol tablets to achieve a minimum symptom state. Second, after the first is complete, participants are trained to self-administer small-dosage, 5-day regimens of cortisol tablets to quench disease exacerbations to maintain the minimum symptom state.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Patient Self-administration of Cortisol for Cortisol-responding Disorders in Men and Women Over the Age of 17, Demonstration of Double-blind Trial Results
• Actual Study Start Date: January 1, 2000
• Actual Primary Completion Date: December 31, 2016
• Actual Study Completion Date: December 31, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Patient self-administration of cortisol; Intervention is patient self-administration of cortisol.	Drug: Cortisol; Participants determine when to administer 5-day regimens of cortisol; Other Name: microdose therapy

Outcome Measures

Primary Outcome Measures :

1. Participant evaluation of disease symptom intensity [ Time Frame: Participants determine Total Scores 7 days prior to cortisol initiation to obtain the average baseline Total Score. Participant Total Score change is plotted daily vs. time for study. Outcome: Total Score at 24 weeks vs. baseline. ]
   Participants evaluate 50 symptoms for intensity using the 0 to 10 scale. 0 represents no disease intensity and 10 represents extreme maximum symptom intensity with the intermediate numbers defined as Mild I, Mild II, Mild III, Moderate I, Moderate II, Moderate III, Severe I, Severe II, Severe III for 2 through 9, respectively. The participant-determined disease intensity numbers of the 50 symptoms are added to obtain Total Score for each day.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Clinical diagnoses of fibromyalgia, osteoarthritis, or rheumatoid arthritis -

Exclusion Criteria:

Congestive heart failure, stomach ulceration, unstable diabetes, and bipolar disorder

-

Contacts and Locations

Locations

United States, Arizona

Helen Foundation Clinic

Apache Junction, Arizona, United States, 85120

Sponsors and Collaborators

Helen Foundation

Investigators

• Principal Investigator: Virgil I Stenberg, Ph.D.; University of North Dakota

More Information

Publications:

Stenberg VI, Fiechtner JJ, Rice JR, Miller DR, Johnson LK. Endocrine control of inflammation: rheumatoid arthritis double-blind, crossover clinical trial. Int J Clin Pharmacol Res. 1992;12(1):11-8.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Irwin JB, Baldwin AL, Stenberg VI. General theory of inflammation: patient self-administration of hydrocortisone safely achieves superior control of hydrocortisone-responding disorders by matching dosage with symptom intensity. J Inflamm Res. 2019 Jun 13;12:161-166. doi: 10.2147/JIR.S195165. eCollection 2019. Erratum in: J Inflamm Res. 2020 May 21;13:207.

• Responsible Party: Helen Foundation
• ClinicalTrials.gov Identifier: NCT03558971
• Other Study ID Numbers: HF 101
• First Posted: June 15, 2018
• Last Update Posted: June 15, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Plan to publish the study, its results and conclusions

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Helen Foundation:

Cortisol

Additional relevant MeSH terms:

Rheumatic Diseases; Collagen Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Hydrocortisone; Anti-Inflammatory Agents