Secondary Adrenal InsufficiencyPhase 4NCT06832566
Ramadan Fasting Outcomes in Patients With Secondary Adrenal Insufficiency Before and After the Treatment of Hypotension.
A Phase 4 study testing Fludrocortisone 0.1 Milligrams (mg) in people with Secondary Adrenal Insufficiency and Hypotension, run by Hopital La Rabta at 1 site in Tunisia.
Trial summary
Intermittent fasting in patients with adrenal insufficiency is associated with an increased risk of complications, such as dehydration. A recent study showed that nearly half the patients had hypotension before the fasting month and half had signs of dehydration during fasting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Adrenal Insufficiency, Hypotension
- What is being tested?
- Fludrocortisone 0.1 Milligrams (mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTunisia
- Study dates
- 15 Feb 2025to 15 Apr 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18 years
- Secondary adrenal insufficiency patients
- Substituted with glucocorticoids for more than one year.
- Participated in the former study in 2023.
- Willing to fast during the month of Ramadan 2025.
Who cannot join
- cardiac, respiratory, hepatic or renal insufficiency (creatinine clearance < 60 ml/min/1.73m2), advanced neoplasia, undernutrition, diabetes insipidus, diabetes mellitus, neuro-psychiatric disease, infectious or chronic inflammatory disease, hyperthyroidism, uncontrolled hypothyroidism, alcoholism, diuretic intake, glucocorticoid treatment for purposes other than substitution, enzyme inducers, pregnancy, breastfeeding.
- consent withdrawn, study discontinuation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site
Hopital La Rabta
Tunis, Tunisia, 1007
Melika Chihaoui, Professor, +21671150832, melikachihaoui@yahoo.fr
Melika Chihaoui, Professor
About this study
Intermittent fasting in patients with adrenal insufficiency is associated with an increased risk of complications, such as dehydration. A recent study showed that nearly half the patients had hypotension before the fasting month and half had signs of dehydration during fasting. So, we are planning to carry out this prospective interventional study in patients with SAI and hypotension to evaluate the effect of treating hypotension with fludrocortisone on the risk of complications during fasting. Patients with secondary adrenal insufficiency and hypotension and who are willing to fast during Ramadan 2025 will be included. Before Ramadan, they will be treated with fludrocortisone at a dose of 50micg/day. The occurrence of complications and the number of fasted days during Ramadan 2025 will be reported and compared with those of Ramadan 2023.
Read the detailed description
Intermittent fasting during Ramadan is practised by more than one billion people worldwide. Patients with adrenal insufficiency are at risk of complications during fasting. The most frequently reported complications were intense asthenia (88.5%), signs suggestive of dehydration (49.2%), intense thirst (32.8%), and signs of hypoglycaemia (18%) Chihaoui M, et al, Endocrine 2017;55:289-295. https://doi.org/10.1007/s12020-016-1186-0). A recent study showed that lifestyle measures and drug adjustment enabled more patients to fast and reduced the frequency of complications. It also showed that nearly half the patients had hypotension before the fasting month and half had signs of dehydration during fasting (ClinicalTrials.gov ID: NCT05827965 ; Chihaoui et al, Nutrition, 2025; https://doi.org/10.1016/j.nut.2025.112688).
The objective of the study is to compare the number of fasted days and the prevalence of complications during Ramadan fasting in patients with SAI before (2023) and after the treatment of hypotension with fludrocortisone (2025).
Keywords: secondary adrenal insufficiency; intermittent fasting; complications; hypotension; fludrocortisone; quality of life
Type of study: Prospective, interventional, before/after study
Study population:
The study will include patients with SAI and hypotension who participated in our former study in 2023 (ClinicalTrials.gov ID: NCT05827965 ; Chihaoui et al, Nutrition, 2025; https://doi.org/10.1016/j.nut.2025.112688). Patients will be included before the month of Ramadan, from February 15th to February 25th, 2025, according to the following selection criteria:
Inclusion criteria:
- Patients aged over 18 years
- Secondary adrenal insufficiency patients
- Substituted with glucocorticoids for more than one year.
- Participated in the former study in 2023.
- Willing to fast during the month of Ramadan 2025.
Exclusion criteria: cardiac, respiratory, hepatic or renal insufficiency (creatinine clearance < 60 ml/min/1.73m2), advanced neoplasia, undernutrition, diabetes insipidus, diabetes mellitus, neuro-psychiatric disease, infectious or chronic inflammatory disease, hyperthyroidism, uncontrolled hypothyroidism, alcoholism, diuretic intake, glucocorticoid treatment for purposes other than substitution, enzyme inducers, pregnancy, breastfeeding, consent withdrawn, study discontinuation.
Study period: February 15th -April 15th. Ramadan starts on March 1st and ends on March 29th, 2025.
Methods Before Ramadan 2025, patients meeting the inclusion criteria will be enrolled. All patients have to sign a written informed consent.
During the first visit (two weeks before Ramadan), the following data will be recorded:
- gender, age, medical and surgical history, current treatments, medication schedule,
- Physical examination data: weight, height, lying and standing blood pressure.
- Some data will be taken from the medical file: other affected pituitary axes, etiology of the SAI, baseline cortisol, and plasma creatinine.
- Data about 2023 fast (number of fasted days, complications (type, days, time, breaking of the fast (yes/no) will collected from our former study.
Fludocortisone at a dose of 50 micg/day will be added to the treatment of the patients.
During the second visit (one week before Ramadan), the quality of life questionnaire (AddiQoL) will be administered to the patients, blood pressure will be measured, and a blood sample will be collected for the measurement of sodium, potassium and urea.
Throughout Ramadan 2025, patients will have to fill in forms indicating the fasted days and the occurrence of complications (type, time, and break of the fast). Patients will be asked to respond to the AddiQoL questionnaire again during the third week of Ramadan.
Throughout the study, regular telephone contact with one of the investigators will be maintained for any additional information, advice or therapeutic adjustment.
After Ramadan, filled addiQoL questionnaires and forms will be collected.
- Conditions
- Secondary Adrenal Insufficiency, Hypotension
- Being tested
- Fludrocortisone 0.1 Milligrams (mg)
- Keywords
- secondary adrenal insufficiency, intermittent fasting, complications, hypotension, fludrocortisone, quality of life
- Medical subject headings
- Hypotension, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludrocortisone 0.1 Milligrams (mg)Drug
Treatment of hypotension with fludrocortisone 0.05mg/day in patients with secondary adrenal insufficiency before Ramadan fasting. Outcomes (number of fasted days and complications during fasting) will be compared between Ramadan fasting 2025 (with fludrocortisone) and Ramadan 2023 (without fludrocortisone).
| Study group | Role | What they receive |
|---|---|---|
| Patients with secondary adrenal insufficiency and hypotension treated with fludrocortisone 0.05mg/d | Experimental | Patients with secondary adrenal insufficiency and hypotension treated with fludrocortisone 0.05mg/day during Ramadan fasting 2025. Receives: Drug: Fludrocortisone 0.1 Milligrams (mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of fasted days
Total days fasted during the month of Ramadan 2025
Measured: One month
Secondary outcomes (1)
complications during fasting
signs of hypotension, dehydration, hypoglycemia..
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start15 Feb 2025 (estimated)
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Secondary 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, interventional, before/after study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital La Rabta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melika Chihaoui, Hopital La Rabta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832566
- Sponsor's protocol ID
- LaRabtaEndocrine1/2025
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chihaoui et al, Nutrition, 2025; https://doi.org/10.1016/j.nut.2025.112688
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ramadan Fasting Outcomes in Patients With Secondary Adrenal Insufficiency Before and After the Treatment of Hypotension.
- ClinicalTrials.gov ID
- NCT06832566
- Acronym / sponsor ID
- LaRabtaEndocrine1/2025
- Conditions
- Secondary Adrenal Insufficiency, Hypotension
- Keywords
- secondary adrenal insufficiency, intermittent fasting, complications, hypotension, fludrocortisone, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hopital La RabtaUniversity, hospital or other
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 18 Feb 2025 (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.
Intermittent fasting in patients with adrenal insufficiency is associated with an increased risk of complications, such as dehydration. A recent study showed that nearly half the patients had hypotension before the fasting month and half had signs of dehydration during fasting. So, we are planning to carry out this prospective interventional study in patients with SAI and hypotension to evaluate the effect of treating hypotension with fludrocortisone on the risk of complications during fasting. Patients with secondary adrenal insufficiency and hypotension and who are willing to fast during Ramadan 2025 will be included. Before Ramadan, they will be treated with fludrocortisone at a dose of 50micg/day. The occurrence of complications and the number of fasted days during Ramadan 2025 will be reported and compared with those of Ramadan 2023.
Detailed description
Intermittent fasting during Ramadan is practised by more than one billion people worldwide. Patients with adrenal insufficiency are at risk of complications during fasting. The most frequently reported complications were intense asthenia (88.5%), signs suggestive of dehydration (49.2%), intense thirst (32.8%), and signs of hypoglycaemia (18%) Chihaoui M, et al, Endocrine 2017;55:289-295. https://doi.org/10.1007/s12020-016-1186-0). A recent study showed that lifestyle measures and drug adjustment enabled more patients to fast and reduced the frequency of complications. It also showed that nearly half the patients had hypotension before the fasting month and half had signs of dehydration during fasting (ClinicalTrials.gov ID: NCT05827965 ; Chihaoui et al, Nutrition, 2025; https://doi.org/10.1016/j.nut.2025.112688).
The objective of the study is to compare the number of fasted days and the prevalence of complications during Ramadan fasting in patients with SAI before (2023) and after the treatment of hypotension with fludrocortisone (2025).
Keywords: secondary adrenal insufficiency; intermittent fasting; complications; hypotension; fludrocortisone; quality of life
Type of study: Prospective, interventional, before/after study
Study population:
The study will include patients with SAI and hypotension who participated in our former study in 2023 (ClinicalTrials.gov ID: NCT05827965 ; Chihaoui et al, Nutrition, 2025; https://doi.org/10.1016/j.nut.2025.112688). Patients will be included before the month of Ramadan, from February 15th to February 25th, 2025, according to the following selection criteria:
Inclusion criteria:
- Patients aged over 18 years
- Secondary adrenal insufficiency patients
- Substituted with glucocorticoids for more than one year.
- Participated in the former study in 2023.
- Willing to fast during the month of Ramadan 2025.
Exclusion criteria: cardiac, respiratory, hepatic or renal insufficiency (creatinine clearance < 60 ml/min/1.73m2), advanced neoplasia, undernutrition, diabetes insipidus, diabetes mellitus, neuro-psychiatric disease, infectious or chronic inflammatory disease, hyperthyroidism, uncontrolled hypothyroidism, alcoholism, diuretic intake, glucocorticoid treatment for purposes other than substitution, enzyme inducers, pregnancy, breastfeeding, consent withdrawn, study discontinuation.
Study period: February 15th -April 15th. Ramadan starts on March 1st and ends on March 29th, 2025.
Methods Before Ramadan 2025, patients meeting the inclusion criteria will be enrolled. All patients have to sign a written informed consent.
During the first visit (two weeks before Ramadan), the following data will be recorded:
- gender, age, medical and surgical history, current treatments, medication schedule,
- Physical examination data: weight, height, lying and standing blood pressure.
- Some data will be taken from the medical file: other affected pituitary axes, etiology of the SAI, baseline cortisol, and plasma creatinine.
- Data about 2023 fast (number of fasted days, complications (type, days, time, breaking of the fast (yes/no) will collected from our former study.
Fludocortisone at a dose of 50 micg/day will be added to the treatment of the patients.
During the second visit (one week before Ramadan), the quality of life questionnaire (AddiQoL) will be administered to the patients, blood pressure will be measured, and a blood sample will be collected for the measurement of sodium, potassium and urea.
Throughout Ramadan 2025, patients will have to fill in forms indicating the fasted days and the occurrence of complications (type, time, and break of the fast). Patients will be asked to respond to the AddiQoL questionnaire again during the third week of Ramadan.
Throughout the study, regular telephone contact with one of the investigators will be maintained for any additional information, advice or therapeutic adjustment.
After Ramadan, filled addiQoL questionnaires and forms will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, interventional, before/after study
| Arm | Type | Receives |
|---|---|---|
| Patients with secondary adrenal insufficiency and hypotension treated with fludrocortisone 0.05mg/d | Experimental | Drug: Fludrocortisone 0.1 Milligrams (mg)Patients with secondary adrenal insufficiency and hypotension treated with fludrocortisone 0.05mg/day during Ramadan fasting 2025. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged over 18 years
- Secondary adrenal insufficiency patients
- Substituted with glucocorticoids for more than one year.
- Participated in the former study in 2023.
- Willing to fast during the month of Ramadan 2025.
Key exclusion criteria (2 listed)
- cardiac, respiratory, hepatic or renal insufficiency (creatinine clearance < 60 ml/min/1.73m2), advanced neoplasia, undernutrition, diabetes insipidus, diabetes mellitus, neuro-psychiatric disease, infectious or chronic inflammatory disease, hyperthyroidism, uncontrolled hypothyroidism, alcoholism, diuretic intake, glucocorticoid treatment for purposes other than substitution, enzyme inducers, pregnancy, breastfeeding.
- consent withdrawn, study discontinuation.
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 |
|---|---|---|
| Fludrocortisone 0.1 Milligrams (mg)Treatment of hypotension with fludrocortisone 0.05mg/day in patients with secondary adrenal insufficiency before Ramadan fasting. Outcomes (number of fasted days and complications during fasting) will be compared between Ramadan fasting 2025 (with fludrocortisone) and Ramadan 2023 (without fludrocortisone). | Drug | Patients with secondary adrenal insufficiency and hypotension treated with fludrocortisone 0.05mg/d |
Primary outcome
number of fasted days
Time frame: One month
Total days fasted during the month of Ramadan 2025
1 secondary outcome
complications during fasting
Time frame: One month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Results publicationChihaoui et al, Nutrition, 2025; https://doi.org/10.1016/j.nut.2025.112688
- Individual participant dataSharing planned: Undecided
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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.
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 Fludrocortisone 0.1 Milligrams (mg) in people with Secondary Adrenal Insufficiency and Hypotension, run by Hopital La Rabta 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 2 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: opening soon, as of the sponsor's last update on 18 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melika Chihaoui, Professor (+21698647327, melika.chihaoui@fmt.utm.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of fasted days (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06832566, which also lists 1 linked publication.
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 18 Feb 2025.