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Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.

NCT05457296 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-07-13

No results posted yet for this study

Summary

Patients with adrenal insufficiency are most often overdosed with hydrocortisone. To date, there is no reliable marker that can reflect the quality of hydrocortisone substitution. Salivary cortisol is a good reflection of free plasmatic cortisol. However, salivary contamination with the oral intake of hydrocortisone has been described.

The aims of the study are to:

* evaluate the frequency of salivary contamination by hydrocortisone taken in tablet form and determine its risk factors.
* evaluate the quality of hydrocortisone substitution in patients with corticotrope deficiency.

Conditions

Interventions

DRUG

Hydrocortisone (capsule)

salivary cortisol measurement at baseline and at one, two, and four hours after hydrocortisone intake.

Sponsors & Collaborators

  • University Tunis El Manar

    lead OTHER

Principal Investigators

  • Meriem Kallel, professor · Research committee of the university hospital La Rabta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Tunisia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05457296 on ClinicalTrials.gov