Ramadan Fasting in Patients With Corticotrope Deficiency Treated Either by Hydrocortisone or by Prednisolone

April 25, 2019 updated by: Melika Chihaoui, University Tunis El Manar

Comparison of the Risk of Complications and the Quality of Life During Ramadan Fasting in Patients With Corticotrope Deficiency Treated Either by Hydrocortisone or by Prednisolone

Selected patients will be randomised to either hydrocortisone or prednisolone. Each treatment period is of 14 days. Abnormal clinical symptoms, blood glucose and quality of life will be monitored.

Study Overview

Status

Completed

Detailed Description

  • Selection of the patients who meet the inclusion and non inclusion criteria.
  • Detailed explanations about the study to the patients.
  • Signature of the informed consent by the patients.
  • Randomisation of the patients by drawing lots into two groups; group AB who will receive treatment A during 14 days (period 1) then treatment B during 14 days (period 2) and group BA who will receive treatment B during 14 days (period 1) then treatment A during 14 days (period 2).
  • Each patient will receive a daily follow-up sheet, a quality of life questionnaire, a glucometer with test strips and the treatment in different bottles for each period of the study.
  • The daily follow-up sheet concerns habits during Ramadan (eating, sleeping), the occurrence of complications and blood glucose monitoring. Daily blood glucose monitoring is requested at midday, before dinner and if a malaise occurs. A detailed questionnaire on abnormal symptoms that might occur during fasting have to be fulfilled for each malaise.
  • Quality of life will be evaluated using AddiQol questionnaire translated in Tunisian dialect. Patients have to complete the questionnaire before the fasting month and at the end of each period of treatment.
  • Treatment is presented in the form of capsules with the same colour and size. Patients have to take one capsule at dinner and one capsule at pre-dawn meal. Patients will receive either hydrocortisone 15mg at pre-dawn meal and 5mg at dinner (sunset) (treatment A) or prednisolone 5mg at pre-dawn meal and a placebo (starch) at dinner (treatment B).
  • During the study, patients will be in regular phone contact with a responsible of the study for any information or problem.
  • At the end of the study, the completed follow-up sheets and questionnaires will be picked up.

Study Type

Interventional

Enrollment (Actual)

53

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 Locations

      • Tunis, Tunisia, 1068
        • University Tunis El Manar

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

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Known corticotrope deficiency treated by 20mg hydrocortisone per day.
  • Age: 18-70 years
  • patients who are willing to fast Ramadan 2018 and who voluntary accept to participate in the study.

Non inclusion criteria:

Patients with either diabetes mellitus, hypertension, diabetes insipidus, severe organ damage (renal, cardiac, pulmonary, hepatic), neoplasia, psychiatric disease, epilepsy or pregnant or breast-feeding women.

Exclusion Criteria:

The occurrence of any of the non inclusion criteria during the study. The occurrence of a severe malaise.

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: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: hydrocortisone
hydrocortisone 20 mg per day: 15 mg at pre-dawn meal and 5 mg at dinner
at a substitutive dosage
Other Names:
  • Cortef*
ACTIVE_COMPARATOR: prednisolone
Prednisolone 5 mg at pre-dawn meal and a placebo (starch) at dinner
at a substitutive dosage
Other Names:
  • Vitapred*

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of complications
Time Frame: during the fourteen days treatment period
fatigue, asthenia, symptoms of hypoglycemia, symptoms of dehydration, hypoglycemia on blood glucose monitoring
during the fourteen days treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
score of quality of life
Time Frame: during the fourteen days treatment period
using a questionnaire (AddiQol)
during the fourteen days treatment period

Collaborators and Investigators

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

Investigators

  • Study Chair: Hedia Slimane, MD, University Tunis El Manar

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 (ACTUAL)

May 17, 2018

Primary Completion (ACTUAL)

June 16, 2018

Study Completion (ACTUAL)

July 25, 2018

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

July 2, 2018

First Posted (ACTUAL)

July 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2019

Last Update Submitted That Met QC Criteria

April 25, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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