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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-17

Study Completion Date

2018-07-25

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.

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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.

Conditions

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Corticotropin Deficiency Fasting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

crossover clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

the treatment has been put in capsules with the same size and color

Study Groups

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hydrocortisone

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

Group Type ACTIVE_COMPARATOR

Hydrocortisone

Intervention Type DRUG

at a substitutive dosage

prednisolone

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

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

at a substitutive dosage

Interventions

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Hydrocortisone

at a substitutive dosage

Intervention Type DRUG

Prednisolone

at a substitutive dosage

Intervention Type DRUG

Other Intervention Names

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Cortef* Vitapred*

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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No