Ramadan Fasting in Patients With Corticotrope Deficiency... | NCT03585829

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

NCT03585829

Sponsor

University Tunis El Manar

Status

Completed

Last Update Posted

Apr 29, 2019Actual

Enrollment

53Actual

Phase

Phase 4

Conditions

Corticotropin Deficiency
Fasting

Interventions

Hydrocortisone
Prednisolone

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 17, 2018Actual

Primary Completion Date

Jun 16, 2018Actual

Completion Date

Jul 25, 2018Actual

First Submitted Date

May 16, 2018

First Submission Date that Met QC Criteria

Jul 2, 2018

First Posted Date

Jul 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2019

Last Update Posted Date

Apr 29, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Melika Chihaoui, Principal investigator, University Tunis El ManarPrincipal Investigator

Lead Sponsor

University Tunis El ManarOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hydrocortisone	Active Comparator	hydrocortisone 20 mg per day: 15 mg at pre-dawn meal and 5 mg at dinner	Drug: Hydrocortisone
prednisolone	Active Comparator	Prednisolone 5 mg at pre-dawn meal and a placebo (starch) at dinner	Drug: Prednisolone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydrocortisone	Drug	at a substitutive dosage	hydrocortisone	Cortef*

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurence of complications	fatigue, asthenia, symptoms of hypoglycemia, symptoms of dehydration, hypoglycemia on blood glucose monitoring	during the fourteen days treatment period

Secondary Outcomes

Measure	Description	Time Frame
score of quality of life	using a questionnaire (AddiQol)	during the fourteen days treatment period

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hedia Slimane, MD	University Tunis El Manar	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Tunis El Manar		Tunis		1068	Tunisia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C535668	Adrenocorticotropic hormone deficiency
D005215	Fasting
D007003	Hypoglycemia

Ancestor Terms

ID	Term
D005247	Feeding Behavior
D001519	Behavior
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006854	Hydrocortisone
D011239	Prednisolone

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided