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

University Tunis El Manar

Status and phase: Completed; Phase 4

Conditions: Corticotropin Deficiency; Fasting

Treatments: Drug: Hydrocortisone; Drug: Prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT03585829

100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

53 participants in 2 patient groups

hydrocortisone

Active Comparator group

Description:

hydrocortisone 20 mg per day: 15 mg at pre-dawn meal and 5 mg at dinner

Treatment:

Drug: Hydrocortisone

prednisolone

Active Comparator group

Description:

Prednisolone 5 mg at pre-dawn meal and a placebo (starch) at dinner

Treatment:

Drug: Prednisolone