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Ramadan Fasting Outcomes in Patients With Secondary Adrenal Insufficiency Before and After the Treatment of Hypotension.

NCT06832566 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-02-18

No results posted yet for this study

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. 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.

Conditions

Interventions

DRUG

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).

Sponsors & Collaborators

  • Hopital La Rabta

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-15
Primary Completion
2025-04-15
Completion
2025-04-15

Countries

  • Tunisia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06832566 on ClinicalTrials.gov