Fasting Clinical Trial
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
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.
- 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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03754920 -
Prolonged Fasting With Meditation and Mild Physical Exercise
|
N/A | |
Completed |
NCT05272332 -
Gastric Ultrasound Prior to Extubation
|
||
Completed |
NCT04247464 -
Short-term Fasting as an Enhancer of Chemotherapy: Pilot Clinical Study on Colorectal Carcinoma Patients
|
N/A | |
Completed |
NCT01067001 -
Minocycline HCl Extended Release Tablets 135 mg Oral Bioequivalence Study
|
N/A | |
Completed |
NCT00757094 -
Safety and Feasibility of Fasting While Receiving Chemotherapy
|
N/A | |
Completed |
NCT01506713 -
Bioequivalence Study of Clopidogrel Tablets 75 mg of Dr. Reddy's Under Fasting Conditions
|
Phase 1 | |
Completed |
NCT04514380 -
Effect of Drinking Carbohydrate-containing Fluids on Gastric Residual Volume in Elderly Patients
|
||
Completed |
NCT05756868 -
The Effect of Time-Restricted Feeding on Anthropometry, Biochemical Parameters, Diet Quality and Eating Behavior
|
N/A | |
Completed |
NCT05134207 -
The Effect of Oral Carbohydrate Solution on Anxiety and Comfort in Patients Undergoing Hip Arthroplasty
|
N/A | |
Completed |
NCT05031598 -
Long-term Fasting: Multi-system Adaptations in Humans
|
N/A | |
Recruiting |
NCT04501393 -
Recommended Clear Fluid Intake Volume at 2 Hours Prior to Esophagogastroduodenoscopy for Adult Patients
|
N/A | |
Enrolling by invitation |
NCT04027478 -
Can Fasting Decrease the Side Effects of Chemotherapy?
|
N/A | |
Completed |
NCT05219136 -
Improve the Comfort, Safety and Quality of Upper Endoscopy by a Modified Fasting Protocol
|
N/A | |
Recruiting |
NCT04625608 -
Effect of Premedicant Oral Paracetamol on Gastric Volume and pH
|
Phase 4 | |
Not yet recruiting |
NCT02562638 -
Pre-Procedural Fasting in Cardiac Intervention
|
N/A | |
Completed |
NCT01954836 -
Short-Term Fasting During Chemotherapy in Patients With Gynecological Cancer- a Randomized Controlled Cross-over Trial
|
N/A | |
Completed |
NCT01949987 -
Does Oral Intake Decreases Postoperative Pain Score in Children
|
N/A | |
Completed |
NCT01746719 -
Bioequivalence Study of Etodolac Capsules USP 300 mg Under Fasting Condition
|
Phase 1 | |
Completed |
NCT01721187 -
Satiety Effects on the Neural Valuation of Food
|
N/A | |
Completed |
NCT01713647 -
Bioequivalence Study of Amlodipine / Losartan/ Hydrochlorothiazide of PHARMALINE, Lebanon Under Fastion Conditions
|
Phase 1 |