Clincosm LogoSign in Get a demo

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

Sponsor
University Tunis El Manar (Other)
Overall Status
Completed
CT.gov ID
NCT03585829
Collaborator
(none)
53
Enrollment
1
Location
2
Arms
2.3
Actual Duration (Months)
23.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed 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

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
crossover clinical trialcrossover clinical trial
Masking:
Double (Participant, Care Provider)
Masking Description:
the treatment has been put in capsules with the same size and color
Primary Purpose:
Treatment
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 :
Jun 16, 2018
Actual Study Completion Date :
Jul 25, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: hydrocortisone

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

Drug: Hydrocortisone
at a substitutive dosage
Other Names:
  • Cortef*

    		•
    Active Comparator: prednisolone

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

    Drug: Prednisolone
    at a substitutive dosage
    Other Names:
  • Vitapred*

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Occurence of complications [during the fourteen days treatment period]

      fatigue, asthenia, symptoms of hypoglycemia, symptoms of dehydration, hypoglycemia on blood glucose monitoring

    Secondary Outcome Measures

    1. score of quality of life [during the fourteen days treatment period]

      using a questionnaire (AddiQol)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Tunis El Manar Tunis Tunisia 1068

    Sponsors and Collaborators

    • University Tunis El Manar

    Investigators

    • Study Chair: Hedia Slimane, MD, University Tunis El Manar

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Melika Chihaoui, Principal investigator, University Tunis El Manar
    ClinicalTrials.gov Identifier:
    NCT03585829
    Other Study ID Numbers:
    • 100
    First Posted:
    Jul 13, 2018
    Last Update Posted:
    Apr 29, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Melika Chihaoui, Principal investigator, University Tunis El Manar
    treatment
    quality of life
    hypoglycemia
    Additional relevant MeSH terms:
    Prednisolone
    Hydrocortisone

    Study Results

    No Results Posted as of Apr 29, 2019