- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03585829
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
Conditions
Intervention / Treatment
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:
|
ACTIVE_COMPARATOR: prednisolone
Prednisolone 5 mg at pre-dawn meal and a placebo (starch) at dinner
|
at a substitutive dosage
Other Names:
|
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100
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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