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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Corticotropin Deficiency, Fasting

Intervention / Treatment
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* Drug: Hydrocortisone
* Drug: Prednisolone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: crossover clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hydrocortisone<br>hydrocortisone 20 mg per day: 15 mg at pre-dawn meal and 5 mg at dinner | Drug: Hydrocortisone<br>* at a substitutive dosage<br>* Other names: Cortef*;|
| Active Comparator: prednisolone<br>Prednisolone 5 mg at pre-dawn meal and a placebo (starch) at dinner | Drug: Prednisolone<br>* at a substitutive dosage<br>* Other names: Vitapred*;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of complications | 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 | using a questionnaire (AddiQol) | during the fourteen days treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment, quality of life, hypoglycemia