CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 63 enrolled
Drug / intervention
Hydrocortisonedrug
Likely dose
Hydrocortisone 0.3 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01546922
NCT01546922Phase 4Completed
CompareCT.gov

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

University Medical Center Groningen·interventional·Posted Mar 7, 2012·Updated Jul 14, 2014

In Brief

A Phase 4 clinical trial evaluating Hydrocortisone for Adrenal Insufficiency. Completed, enrolled 63 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdrenal Insufficiency
CountriesNetherlands
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 7, 2012
Enrollment StartFeb 1, 2012
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.3 years ago

Interventions

Hydrocortisonedrug

Patients receive either a low dose HC (0.2-0.3 mg/kg body weight) for 10 weeks followed by 10 weeks of high dose HC (0.4-0.6 mg/kg body weight) or vice versa.