Ignite Creation Date:
2024-05-06 @ 12:18 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01546922
Status:
COMPLETED
Last Update Posted:
2014-07-14
First Post:
2012-02-07
Brief Title:
Hydrocortisone Replacement in Patients With Secondary Adrenal Insufficiency SUPREME CORT
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
A Randomized Double Blind Cross-over Study of the Effects of Low Dose and High Dose Hydrocortisone Replacement Therapy on Cognition Quality of Life Metabolic Profile and Somatosensation in Patients With Secondary Adrenal Insufficiency
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUPREME CORT
Brief 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
Detailed Description:
Rationale A wide variety in hydrocortisone HC substitution dose-regimens are considered physiological for patients with adrenal insufficiency However it is likely that cognition is negatively influenced by higher cortisol exposure to the brain No studies have been performed to assess the effects of treatment regimens with a low physiological HC substitution dose on cognition in comparison to a high physiological HC substitution dose These treatment regimens should take body weight and multiple dosing into account In addition substitution doses should be monitored by clinical evaluation and biochemical analysis for adverse effects associated with over- or under-replacement
Intervention Patients with secondary adrenal insufficiency will be randomized in two groups to receive either a low dose HC 02-03 mgkg body weight for 10 weeks followed by 10 weeks of high dose HC 04-06 mgkg body weight or vice versa At baseline and after both treatment periods patients will be tested
Intervention Patients with secondary adrenal insufficiency will be randomized in two groups to receive either a low dose HC 02-03 mgkg body weight for 10 weeks followed by 10 weeks of high dose HC 04-06 mgkg body weight or vice versa At baseline and after both treatment periods patients will be tested
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-000864-82 | EUDRACT_NUMBER | None | None |