Phase 4 N=60 Randomized Double-blind Treatment

Hydrocortisone Replacement in Patients With Secondary Adrenal Insufficiency (SUPREME CORT)

Adrenal Insufficiency

Bottom Line

View on ClinicalTrials.gov: NCT01546922 ↗

Enrolled (actual)

Serious AEs

1.8%

Results posted

Jul 2014

Primary outcome: Primary: Change in Cognition After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone. — -0.41; -0.42; 0.07; 0.10 Z-scores based on normative data. — p=0.861

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Hydrocortisone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University Medical Center Groningen
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Cognition After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.	-0.41; -0.42; 0.07; 0.10; 0.85; 0.89	0.861
SECONDARY Change in Quality of Life After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.	—	—
SECONDARY Change in Metabolic Profile After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.	—	—
SECONDARY Change in Somatosensation After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.	—	—
SECONDARY Change in Perceived Common Somatic Complaints After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.	—	—

Summary

The aim of this study is to investigate whether a physiologically low hydrocortisone (HC) dose is better for cognition as compared to a physiologically high HC dose. In addition, quality of life, metabolic profile and somatosensation will be described in relation to HC dose.

Eligibility Criteria

Inclusion Criteria

Patients with secondary adrenal insufficiency.
Age ≥ 18 - 75 years
≥ One year after tumor treatment with surgery and/or radiotherapy
On stable concomitant medications for at least six months prior to entry of study
Body weight 50-100 kg

Exclusion Criteria

Inability of legal consent
Documented cognitive impairment
Drug abuse/dependence
History of / current psychiatric disorders
Use of anti-epileptics (e.g. carbamezapine)
Cushing Disease
Type 1 diabetes or Type 2 diabetes with medication known to induce hypoglycemia (f.e. Sulfonylurea derivatives
Current treatment for second malignancy
Have a significant medical condition (e.g. hepatic, respiratory, or cardiovascular) which, in the opinion of the investigator, may interfere with the interpretation of results and safety or efficacy evaluations.
A history of frequent hypocortisolism
Hospitalization during study
Work in shifts

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Data sourced from ClinicalTrials.gov (NCT01546922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.