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

NCT03585829 | Completed Phase 4

• 1 other identifier: 100
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Corticotropin Deficiency; Fasting

Keywords

treatment; quality of life; hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Occurence of complications

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

  during the fourteen days treatment period

Secondary Outcomes (1)

• score of quality of life

  during the fourteen days treatment period

Study Arms (2)

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

Hydrocortisone DRUG

at a substitutive dosage

Also known as: Cortef*

hydrocortisone

Prednisolone DRUG

at a substitutive dosage

Also known as: Vitapred*

prednisolone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

University Tunis El Manar

Tunis, 1068, Tunisia

Location

MeSH Terms

Conditions

Adrenocorticotropic hormone deficiency; Fasting; Hypoglycemia

Interventions

Hydrocortisone; Prednisolone

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Pregnadienetriols; Pregnadienes

Study Officials

• Hedia Slimane, MD

  University Tunis El Manar

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: the treatment has been put in capsules with the same size and color
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: crossover clinical trial

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: July 13, 2018
• Study Start: May 17, 2018
• Primary Completion: June 16, 2018
• Study Completion: July 25, 2018
• Last Updated: April 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)