Adrenal InsufficiencyPhase 4NCT05457296
Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.
A Phase 4 study testing Hydrocortisone (capsule) in people with Adrenal Insufficiency, run by University Tunis El Manar at 2 sites in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Adrenal Insufficiency
- What is being tested?
- Hydrocortisone (capsule)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTunisia
- Study dates
- 1 Jan 2021to 30 Apr 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -patients with corticotrope deficiency treated with hydrocortisone for at least one year.
Who cannot join
- alcoholism,
- morbid obesity,
- long standing or uncontrolled diabetes mellitus,
- uncontrolled hypothyroidism,
- depression,
- chronic or acute inflammatory or infectious disease,
Show all 11Show fewer
- neoplasia,
- renal or hepatic disease,
- malabsorption,
- pregnant or breast-feeding women,
- treatment with corticosteroids other than hydrocortisone, enzyme inducers or oestrogens.
Trial locations and contacts
2 sites in 1 country.
Tunisia2 sites
university hospital La Rabta
Tunis, 1007
University hospital La Rabta
Tunis, 1068
About this study
Official title: Saliva Cortisol Measurement for the Assessment of Hydrocortisone Replacement Therapy in Secondary Adrenal Insufficiency Patients
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.
Read the detailed description
Patients with adrenal insufficiency are most often overdosed with hydrocortisone, as evidenced by the higher frequency of metabolic disorders, osteoporosis and cardiovascular mortality in these subjects compared to healthy subjects. 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.
It is a cross over clinical trial with three arms: patients taking tablets of hydrocortisone, patients taking capsules of hydrocortisone, and healthy control subjects undergoing one day test. Salivary cortisol is measured before, at one, two and four hours after hydrocortisone intake.
- Conditions
- Adrenal Insufficiency
- Being tested
- Hydrocortisone (capsule)
- Keywords
- Adrenal Insufficiency, hydrocortisone, salivary cortisol, pharmacokinetic
- Medical subject headings
- Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone (capsule)Drug
salivary cortisol measurement at baseline and at one, two, and four hours after hydrocortisone intake.
| Study group | Role | What they receive |
|---|---|---|
| capsule hydrocortisone intake in patients with corticotrope deficiency | Experimental | Hydrocortisone taken in capsule form (15mg), one intake/ one day test. Receives: Drug: Hydrocortisone (capsule) |
| tablet hydrocortisone intake in patients with corticotrope deficiency | Active comparator | Hydrocortisone taken in tablet form (15mg), one intake/ one day test. Receives: Drug: Hydrocortisone (capsule) |
| healthy controls | No intervention | healthy non treated controls, one day test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral contamination of salivary cortisol measurement with hydrocortisone taken in tablet form.
very high salivary cortisol levels after the intake of hydrocortisone in tablet form as compared with capsule form.
Measured: during the four hours test
Secondary outcomes (1)
Evaluation of the quality of the substitution of corticotrope deficiency with hydrocortisone using salivary cortisol measurement
patients under-treated, over-treated or well treated (comparison of salivary cortisol levels with those of healthy controls)
Measured: salivary cortisol levels during the four hours test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Jan 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- prospective case control and randomized crossover clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melika Chihaoui, University Tunis El Manar
- Investigators
- Meriem Kallel, professor, Study chair, Research committee of the university hospital La Rabta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457296
- Sponsor's protocol ID
- 101
- Status last verified
- Jul 2022
- First submitted
- 3 Mar 2021
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saliva Cortisol Measurement for the Assessment of Hydrocortisone Replacement Therapy in Secondary Adrenal Insufficiency Patients
- ClinicalTrials.gov ID
- NCT05457296
- Acronym / sponsor ID
- 101
- Conditions
- Adrenal Insufficiency
- Keywords
- Adrenal Insufficiency, hydrocortisone, salivary cortisol, pharmacokinetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with adrenal insufficiency are most often overdosed with hydrocortisone, as evidenced by the higher frequency of metabolic disorders, osteoporosis and cardiovascular mortality in these subjects compared to healthy subjects. 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.
It is a cross over clinical trial with three arms: patients taking tablets of hydrocortisone, patients taking capsules of hydrocortisone, and healthy control subjects undergoing one day test. Salivary cortisol is measured before, at one, two and four hours after hydrocortisone intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- prospective case control and randomized crossover clinical trial
| Arm | Type | Receives |
|---|---|---|
| capsule hydrocortisone intake in patients with corticotrope deficiency | Experimental | Drug: Hydrocortisone (capsule)Hydrocortisone taken in capsule form (15mg), one intake/ one day test. |
| tablet hydrocortisone intake in patients with corticotrope deficiency | Active comparator | Drug: Hydrocortisone (capsule)Hydrocortisone taken in tablet form (15mg), one intake/ one day test. |
| healthy controls | No intervention | –healthy non treated controls, one day test. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -patients with corticotrope deficiency treated with hydrocortisone for at least one year.
Key exclusion criteria (11 listed)
- alcoholism,
- morbid obesity,
- long standing or uncontrolled diabetes mellitus,
- uncontrolled hypothyroidism,
- depression,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocortisone (capsule)salivary cortisol measurement at baseline and at one, two, and four hours after hydrocortisone intake. | Drug | capsule hydrocortisone intake in patients with corticotrope deficiency, tablet hydrocortisone intake in patients with corticotrope deficiency |
Primary outcome
Oral contamination of salivary cortisol measurement with hydrocortisone taken in tablet form.
Time frame: during the four hours test
very high salivary cortisol levels after the intake of hydrocortisone in tablet form as compared with capsule form.
1 secondary outcome
Evaluation of the quality of the substitution of corticotrope deficiency with hydrocortisone using salivary cortisol measurement
Time frame: salivary cortisol levels during the four hours test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meriem Kallel, professor study chair
Research committee of the university hospital La Rabta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocortisone (capsule) in people with Adrenal Insufficiency, run by University Tunis El Manar at 2 sites in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral contamination of salivary cortisol measurement with hydrocortisone taken in tablet form. (time frame: during the four hours test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.