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

February 12, 2025 updated by: Melika Chihaoui, Hopital La Rabta
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Tunisia
      • Tunis, Tunisia, 1007
        • Hopital La Rabta
        • Contact:
        • Contact:
          • Melika Chihaoui, Professor
        • Contact:
          • Mariam Mabrouk, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with secondary adrenal insufficiency and hypotension treated with fludrocortisone 0.05mg/d
Patients with secondary adrenal insufficiency and hypotension treated with fludrocortisone 0.05mg/day during Ramadan fasting 2025.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of fasted days
Time Frame: One month
Total days fasted during the month of Ramadan 2025
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications during fasting
Time Frame: One month
signs of hypotension, dehydration, hypoglycemia..
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital La Rabta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Chihaoui et al, Nutrition, 2025; https://doi.org/10.1016/j.nut.2025.112688

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2025

Primary Completion (Estimated)

April 15, 2025

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LaRabtaEndocrine1/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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