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NCT06832566
Ramadan Fasting Outcomes in Patients With Secondary Adrenal Insufficiency Before and After the Treatment of Hypotension.
Phase 4 trial testing Fludrocortisone 0.1 Milligrams (mg) in Secondary Adrenal Insufficiency in 20 participants. Not yet recruiting.
15 April 2025
Quick facts
| Lead sponsor | Hopital La Rabta |
|---|---|
| Phase | Phase 4 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 15 February 2025 |
| Primary completion | 15 April 2025 |
| Estimated completion | 15 April 2025 |
| Sites | 1 location across Tunisia |
Drugs / interventions tested
- Fludrocortisone 0.1 Milligrams (mg) — full drug profile →
Conditions studied
- Secondary Adrenal Insufficiency — all drugs for Secondary Adrenal Insufficiency →
- Hypotension — all drugs for Hypotension →
Sponsor
Hopital La Rabta — full company profile →
Who can join
18 and older, any sex, with Secondary Adrenal Insufficiency or Hypotension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06832566
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
Other trials of Fludrocortisone 0.1 Milligrams (mg)
Trials testing the same drug.
- NCT04351126 — Management of Ovarian Hyperstimulation Syndrome as a State of Defective Mineralocorticoid Response · Phase 2 · completed
Other Hopital La Rabta trials
Trials by the same sponsor.
- NCT07367425 — Risks of Ramadan Fasting in Patients With Primary Adrenal Insufficiency Treated With Prednisolone. · NA · not yet recruiting
- NCT06299020 — Risks of Intermittent Fasting in Patients With Primary Adrenal Insufficiency · NA · completed
- NCT05827965 — Ramadan Fasting in Secondary Adrenal Insufficiency Patients · NA · completed
- NCT05806723 — Effects of High Intensity Statin Therapy on Steroid Hormones and Vitamin D in Type 2 Diabetic Men · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06832566 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hopital La Rabta
- Last refreshed: 18 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06832566.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing