Ramadan Fasting in Patients With Corticotrope Deficiency Treated Either by Hydrocortisone or by Prednisolone
|ClinicalTrials.gov Identifier: NCT03585829|
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : April 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Corticotropin Deficiency Fasting||Drug: Hydrocortisone Drug: Prednisolone||Phase 4|
- 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 (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||crossover clinical trial|
|Masking:||Double (Participant, Care Provider)|
|Masking Description:||the treatment has been put in capsules with the same size and color|
|Official Title:||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|
|Actual Study Start Date :||May 17, 2018|
|Actual Primary Completion Date :||June 16, 2018|
|Actual Study Completion Date :||July 25, 2018|
Active Comparator: hydrocortisone
hydrocortisone 20 mg per day: 15 mg at pre-dawn meal and 5 mg at dinner
at a substitutive dosage
Other Name: Cortef*
Active Comparator: prednisolone
Prednisolone 5 mg at pre-dawn meal and a placebo (starch) at dinner
at a substitutive dosage
Other Name: Vitapred*
- Occurence of complications [ Time Frame: during the fourteen days treatment period ]fatigue, asthenia, symptoms of hypoglycemia, symptoms of dehydration, hypoglycemia on blood glucose monitoring
- score of quality of life [ Time Frame: during the fourteen days treatment period ]using a questionnaire (AddiQol)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585829
|University Tunis El Manar|
|Tunis, Tunisia, 1068|
|Study Chair:||Hedia Slimane, MD||University Tunis El Manar|