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

Fasting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585829
• Other study ID #: 100
• Status: Completed
• Phase: Phase 4
• Start date: May 17, 2018
• Est. completion date: July 25, 2018

Study information

• Verified date: April 2019
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 25, 2018
• Est. primary completion date: June 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corticotropin Deficiency
• Fasting

Intervention

Drug:
• Hydrocortisone
at a substitutive dosage
• Prednisolone
at a substitutive dosage

Locations

Country	Name	City	State
Tunisia	University Tunis El Manar	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of complications	fatigue, asthenia, symptoms of hypoglycemia, symptoms of dehydration, hypoglycemia on blood glucose monitoring	during the fourteen days treatment period
Secondary	score of quality of life	using a questionnaire (AddiQol)	during the fourteen days treatment period