Corticotropin DeficiencyPhase 4NCT03585829
Ramadan Fasting in Patients With Corticotrope Deficiency Treated Either by Hydrocortisone or by Prednisolone
A Phase 4 study testing Hydrocortisone and Prednisolone in people with Corticotropin Deficiency and Fasting, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Selected patients will be randomised to either hydrocortisone or prednisolone. Each treatment period is of 14 days. Abnormal clinical symptoms, blood glucose and quality of life will be monitored. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Corticotropin Deficiency, Fasting
- What is being tested?
- Hydrocortisone and Prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteTunisia
- Study dates
- 17 May 2018to 25 Jul 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known corticotrope deficiency treated by 20mg hydrocortisone per day.
- Age: 18-70 years
- patients who are willing to fast Ramadan 2018 and who voluntary accept to participate in the study.
- Non inclusion criteria:
- Patients with either diabetes mellitus, hypertension, diabetes insipidus, severe organ damage (renal, cardiac, pulmonary, hepatic), neoplasia, psychiatric disease, epilepsy or pregnant or breast-feeding women.
Who cannot join
- The occurrence of any of the non inclusion criteria during the study. The occurrence of a severe malaise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Risk of Complications and the Quality of Life During Ramadan Fasting in Patients With Corticotrope Deficiency Treated Either by Hydrocortisone or by Prednisolone
Selected patients will be randomised to either hydrocortisone or prednisolone. Each treatment period is of 14 days. Abnormal clinical symptoms, blood glucose and quality of life will be monitored.
Read the detailed description
- Selection of the patients who meet the inclusion and non inclusion criteria.
- Detailed explanations about the study to the patients.
- Signature of the informed consent by the patients.
- Randomisation of the patients by drawing lots into two groups; group AB who will receive treatment A during 14 days (period 1) then treatment B during 14 days (period 2) and group BA who will receive treatment B during 14 days (period 1) then treatment A during 14 days (period 2).
- Each patient will receive a daily follow-up sheet, a quality of life questionnaire, a glucometer with test strips and the treatment in different bottles for each period of the study.
- The daily follow-up sheet concerns habits during Ramadan (eating, sleeping), the occurrence of complications and blood glucose monitoring. Daily blood glucose monitoring is requested at midday, before dinner and if a malaise occurs. A detailed questionnaire on abnormal symptoms that might occur during fasting have to be fulfilled for each malaise.
- Quality of life will be evaluated using AddiQol questionnaire translated in Tunisian dialect. Patients have to complete the questionnaire before the fasting month and at the end of each period of treatment.
- Treatment is presented in the form of capsules with the same colour and size. Patients have to take one capsule at dinner and one capsule at pre-dawn meal. Patients will receive either hydrocortisone 15mg at pre-dawn meal and 5mg at dinner (sunset) (treatment A) or prednisolone 5mg at pre-dawn meal and a placebo (starch) at dinner (treatment B).
- During the study, patients will be in regular phone contact with a responsible of the study for any information or problem.
- At the end of the study, the completed follow-up sheets and questionnaires will be picked up.
- Conditions
- Corticotropin Deficiency, Fasting
- Being tested
- Hydrocortisone, Prednisolone
- Keywords
- treatment, quality of life, hypoglycemia
- Medical subject headings
- Adrenocorticotropic hormone deficiency, Fasting, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Also called Cortef*
at a substitutive dosage
PrednisoloneDrug
Also called Vitapred*
at a substitutive dosage
| Study group | Role | What they receive |
|---|---|---|
| hydrocortisone | Active comparator | hydrocortisone 20 mg per day: 15 mg at pre-dawn meal and 5 mg at dinner Receives: Drug: Hydrocortisone |
| prednisolone | Active comparator | Prednisolone 5 mg at pre-dawn meal and a placebo (starch) at dinner Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of complications
fatigue, asthenia, symptoms of hypoglycemia, symptoms of dehydration, hypoglycemia on blood glucose monitoring
Measured: during the fourteen days treatment period
Secondary outcomes (1)
score of quality of life
using a questionnaire (AddiQol)
Measured: during the fourteen days treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start17 May 2018
- Primary completion16 Jun 2018
- Study completion25 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corticotropin DeficiencyStudies 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
- crossover clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 53 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
- Hedia Slimane, MD, Study chair, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585829
- Sponsor's protocol ID
- 100
- Status last verified
- Apr 2019
- First submitted
- 16 May 2018
- Last updated
- 29 Apr 2019
- 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 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Risk of Complications and the Quality of Life During Ramadan Fasting in Patients With Corticotrope Deficiency Treated Either by Hydrocortisone or by Prednisolone
- ClinicalTrials.gov ID
- NCT03585829
- Acronym / sponsor ID
- 100
- Conditions
- Corticotropin Deficiency, Fasting
- Keywords
- treatment, quality of life, hypoglycemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 17 May 2018 (actual)
- Primary completion
- 16 Jun 2018 (actual)
- Study completion
- 25 Jul 2018 (actual)
- First posted
- 13 Jul 2018 (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.
Selected patients will be randomised to either hydrocortisone or prednisolone. Each treatment period is of 14 days. Abnormal clinical symptoms, blood glucose and quality of life will be monitored.
Detailed description
- Selection of the patients who meet the inclusion and non inclusion criteria.
- Detailed explanations about the study to the patients.
- Signature of the informed consent by the patients.
- Randomisation of the patients by drawing lots into two groups; group AB who will receive treatment A during 14 days (period 1) then treatment B during 14 days (period 2) and group BA who will receive treatment B during 14 days (period 1) then treatment A during 14 days (period 2).
- Each patient will receive a daily follow-up sheet, a quality of life questionnaire, a glucometer with test strips and the treatment in different bottles for each period of the study.
- The daily follow-up sheet concerns habits during Ramadan (eating, sleeping), the occurrence of complications and blood glucose monitoring. Daily blood glucose monitoring is requested at midday, before dinner and if a malaise occurs. A detailed questionnaire on abnormal symptoms that might occur during fasting have to be fulfilled for each malaise.
- Quality of life will be evaluated using AddiQol questionnaire translated in Tunisian dialect. Patients have to complete the questionnaire before the fasting month and at the end of each period of treatment.
- Treatment is presented in the form of capsules with the same colour and size. Patients have to take one capsule at dinner and one capsule at pre-dawn meal. Patients will receive either hydrocortisone 15mg at pre-dawn meal and 5mg at dinner (sunset) (treatment A) or prednisolone 5mg at pre-dawn meal and a placebo (starch) at dinner (treatment B).
- During the study, patients will be in regular phone contact with a responsible of the study for any information or problem.
- At the end of the study, the completed follow-up sheets and questionnaires will be picked up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- crossover clinical trial
| Arm | Type | Receives |
|---|---|---|
| hydrocortisone | Active comparator | Drug: Hydrocortisonehydrocortisone 20 mg per day: 15 mg at pre-dawn meal and 5 mg at dinner |
| prednisolone | Active comparator | Drug: PrednisolonePrednisolone 5 mg at pre-dawn meal and a placebo (starch) at dinner |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Known corticotrope deficiency treated by 20mg hydrocortisone per day.
- Age: 18-70 years
- patients who are willing to fast Ramadan 2018 and who voluntary accept to participate in the study.
- Patients with either diabetes mellitus, hypertension, diabetes insipidus, severe organ damage (renal, cardiac, pulmonary, hepatic), neoplasia, psychiatric disease, epilepsy or pregnant or breast-feeding women.
Key exclusion criteria (1 listed)
- The occurrence of any of the non inclusion criteria during the study. The occurrence of a severe malaise.
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 |
|---|---|---|
| HydrocortisoneAlso: Cortef*at a substitutive dosage | Drug | hydrocortisone |
| PrednisoloneAlso: Vitapred*at a substitutive dosage | Drug | prednisolone |
Primary outcome
Occurence of complications
Time frame: during the fourteen days treatment period
fatigue, asthenia, symptoms of hypoglycemia, symptoms of dehydration, hypoglycemia on blood glucose monitoring
1 secondary outcome
score of quality of life
Time frame: during the fourteen days treatment period
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 29 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Corticotropin Deficiency
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
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.
Hedia Slimane, MD study chair
University Tunis El Manar
1 site 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 and Prednisolone in people with Corticotropin Deficiency and Fasting, run by University Tunis El Manar at 1 site 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 5 inclusion and 1 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 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Occurence of complications (time frame: during the fourteen days treatment period). 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 29 Apr 2019.