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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03585829
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Melika Chihaoui, University Tunis El Manar

Tracking Information
First Submitted Date  ICMJE May 16, 2018
First Posted Date  ICMJE July 13, 2018
Last Update Posted Date April 29, 2019
Actual Study Start Date  ICMJE May 17, 2018
Actual Primary Completion Date June 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2018)
Occurence of complications [ Time Frame: during the fourteen days treatment period ]
fatigue, asthenia, symptoms of hypoglycemia, symptoms of dehydration, hypoglycemia on blood glucose monitoring
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03585829 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
score of quality of life [ Time Frame: during the fourteen days treatment period ]
using a questionnaire (AddiQol)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2018)
quality of life [ Time Frame: during the fourteen days treatment period ]
using a questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ramadan Fasting in Patients With Corticotrope Deficiency Treated Either by Hydrocortisone or by Prednisolone
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
crossover 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
Condition  ICMJE
  • Corticotropin Deficiency
  • Fasting
Intervention  ICMJE
  • Drug: Hydrocortisone
    at a substitutive dosage
    Other Name: Cortef*
  • Drug: Prednisolone
    at a substitutive dosage
    Other Name: Vitapred*
Study Arms  ICMJE
  • Active Comparator: hydrocortisone
    hydrocortisone 20 mg per day: 15 mg at pre-dawn meal and 5 mg at dinner
    Intervention: Drug: Hydrocortisone
  • Active Comparator: prednisolone
    Prednisolone 5 mg at pre-dawn meal and a placebo (starch) at dinner
    Intervention: Drug: Prednisolone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2019)
53
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2018)
60
Actual Study Completion Date  ICMJE July 25, 2018
Actual Primary Completion Date June 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03585829
Other Study ID Numbers  ICMJE 100
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Melika Chihaoui, University Tunis El Manar
Study Sponsor  ICMJE University Tunis El Manar
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hedia Slimane, MD University Tunis El Manar
PRS Account University Tunis El Manar
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP