Is a Diet Necessary When Corticosteroid Treatment is Prescribed?

NCT ID: NCT01420133

Last Updated: 2015-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-10-31

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 diet low in salt and sugar in patients undergoing corticosteroid therapy, to record side effects observed and to measure their frequency.

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 any diet to prevent the occurrence of side effects of steroids such as hypertension, obesity, diabetes and congestive heart.

However, there is no specific dietary requirements in other European countries. This lack of recommendations is based on the fact that there is no evidence that a strict diet reduces the side effects of steroids on the one hand and secondly, that the quality of life of patients undergoing a diet low in salt and low in sugars affects their quality of life. In addition, no prospective study has helped to establish the frequency of side effects of corticosteroids depending on dose and duration of treatment.

The investigators therefore propose to study whether a diet intervention with low salt or low sugar during a prolonged corticosteroid treatment has any interest and effectively reduces the frequency and severity of side effects.

The investigators propose that all parameters being equal, to randomize the diet of patients started on steroids for a predictable period of 3 months minimum for a dose greater than 20 mg per day. One group will observe the low-salt diet, low in sugar and the other will follow a normal diet. The assessment will be made after 1 year, even if steroid treatment is continued beyond.

Conditions

Autoimmune Diseases; Asthma

Keywords

Corticosteroids; Diet low in sugar and salt; Dermatological disease; Corticosteroids Allergy; 3 Months

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Normal regimen

without special regimen for corticosteroid therapy

Group Type: EXPERIMENTAL

Regimen

Intervention Type: OTHER

regimen normal in salt and sugar

Standard arm

with diet low in salt and sugar

Group Type: ACTIVE_COMPARATOR

Standard regimen

Intervention Type: OTHER

with diet low in salt and sugar

Interventions

Regimen

regimen normal in salt and sugar

Intervention Type: OTHER

Standard regimen

with diet low in salt and sugar

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Loic Guillevin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Jessie Aouizerate, MD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

Cochin Hospital

Paris, , France

Countries

France

Other Identifiers

AFSSAPS

Identifier Type: OTHER

Identifier Source: secondary_id

K080906

Identifier Type: -

Identifier Source: org_study_id