Ramadan Fasting Outcomes in Patients With Secondary Adrenal Insufficiency Before and After the Treatment of Hypotension.
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHopital La Rabta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged over 18 years
Secondary adrenal insufficiency patients
Substituted with glucocorticoids for more than one year.
Participated in the former study in 2023.
Disqualifiers
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consent withdrawn, study discontinuation.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 design
Design model
Single group
Treatments tested in this trial
Fludrocortisone 0.1 Milligrams (mg)
DrugTreatment 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).
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Patients with secondary adrenal insufficiency and hypotension treated with fludrocortisone 0.05mg/dExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
number of fasted days
Total days fasted during the month of Ramadan 2025
Time frame
One monthSecondary outcomes
1
complications during fasting
signs of hypotension, dehydration, hypoglycemia..
Time frame
One monthSponsors and contacts
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Source ClinicalTrials.gov
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