Fasting Clinical Trial - Ramadan Fasting in Patients With Corticotrope

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03585829
Study type	Interventional
Source	University Tunis El Manar
Contact
Status	Completed
Phase	Phase 4
Start date	May 17, 2018
Completion date	July 25, 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms