Status:
COMPLETED
Is a Diet Necessary When Corticosteroid Treatment is Prescribed?
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Autoimmune Diseases
Asthma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Few recommendations concerning the diet and dosage to be administered to patients treated with corticosteroids are established. It therefore seems important to study prospectively the indication of a...
Detailed Description
In the French clinical patterns governing the prescription of corticosteroids, it is customary to prescribe a diet low in salt and low in sugar. This dietary prescription is based on the interest of a...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Age \> 18 years
- All patients for whom corticoids initially prescribed at a dose \> 20 mg per 24 hours, during a period of 3 months minimum
- Corticotherapy should be prescribed per os and continuously. (Alternating doses of corticoids, sequential intramuscular or intravenous injection of corticoids are not allowed in this clinical trial)
- All diseases requiring corticotherapy may be subject to this clinical trial. The main pathologies will be systemic autoimmune diseases, asthma or chronic skin diseases justifying prolonged oral corticotherapy.
- Time between first corticoids delivery and randomization \< 1 month
- Patient who gave his non-opposition
- Note: Depending on their health condition, patient may receive one or more intravenous injections of methylprednisolone (until 3 injections), before the beginning of oral corticotherapy.
- Exclusion criteria :
- Age \< 18 years or whose disability warrants a guardianship
- All patients for whom corticoids prescribed \<20 mg per 24 hours or for an expected period \<3 months
- Intramuscular or intravenous sequential corticoids delivery, without associated per os corticoids.
- Any corticotherapies other than prednisone, prednisolone or methylprednisolone.
- Any corticotherapies with alternating doses
- Intravenous or intramuscular injection corticotherapy
- Patient who received corticoids at a dose \>20 mg / day, during 3 last years
- Allergy, hypersensitivity or cons-indication to corticoids
- The existence of diabetes before corticotherapy, because pre-existing diabetes requires specific follow-up treatment, such as sugars restrictions
- Uncontrolled hypertension (SBP ≥ 180mHg or DBP ≥ 110mHg)
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01420133
Start Date
November 1 2011
End Date
October 1 2015
Last Update
December 22 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cochin Hospital
Paris, France, 75014