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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

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
Corticotropin Deficiency Fasting Drug: Hydrocortisone Drug: Prednisolone 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
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
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 : June 16, 2018
Actual Study Completion Date : July 25, 2018


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 Name: Cortef*

Active Comparator: prednisolone
Prednisolone 5 mg at pre-dawn meal and a placebo (starch) at dinner
Drug: Prednisolone
at a substitutive dosage
Other Name: Vitapred*




Primary Outcome Measures :
  1. Occurence of complications [ Time Frame: 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 [ Time Frame: during the fourteen days treatment period ]
    using a questionnaire (AddiQol)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585829


Locations
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Tunisia
University Tunis El Manar
Tunis, Tunisia, 1068
Sponsors and Collaborators
University Tunis El Manar
Investigators
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Study Chair: Hedia Slimane, MD University Tunis El Manar

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Responsible Party: Melika Chihaoui, Principal investigator, University Tunis El Manar
ClinicalTrials.gov Identifier: NCT03585829     History of Changes
Other Study ID Numbers: 100
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Melika Chihaoui, University Tunis El Manar:
treatment
quality of life
hypoglycemia

Additional relevant MeSH terms:
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Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents