Is a Diet Necessary When Corticosteroid Treatment is Prescribed? (Cortisel)

Is a Low Salt Diet and Low Sugar Content Necessary When Corticosteroid Treatment is Prescribed?

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.

Study Overview

• Status: Completed
• Conditions: Autoimmune Diseases; Asthma
• Intervention / Treatment: Other: Regimen; Other: Standard regimen

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Cochin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal regimen; without special regimen for corticosteroid therapy	Other: Regimen; regimen normal in salt and sugar
Active Comparator: Standard arm; with diet low in salt and sugar	Other: Standard regimen; with diet low in salt and sugar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative number of clinical events recorded during the study, per randomization group	Cumulative number of the following clinical events recorded during the study, per randomization group: Weight gain between study entry and the end of it; Significant rise in blood pressure between study entry and the end of it; Development of diabetes requiring treatment, whether prescribed oral or injectable and defined by international criteria of fasting glucose> 7 mmol / fasting twice or post prandial > 11,1 mmol/l twice; Occurrence of heart failure	24 months
Observance of the diet low in salt and sugar will be estimated by patient questionnaire and diary		12 months
Tolerance of the diet low in salt and sugar will be estimated by patient questionnaire and diary		12 months
Observance of the diet low in salt and sugar will be estimated by patient questionnaire and diary		6 months
Tolerance of the diet low in salt and sugar will be estimated by patient questionnaire and diary		6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sides effects of corticosteroids therapy	frequency of sides effects	24 months
Impaired glucide metabolism	surveillance of creatininemia, urinary and serum electrolytes changes; Glucose regulation change observed by blood glucose, insulin, QUICKI and OGTT tests performed at the beginning and the end of the study.; Evaluation of the pancreatic beta cell function (HOMA-B%) estimated as Matthews et al., 1985 done.	24 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Loic Guillevin, MD, PhD, Assistance Publique - Hopitaux de Paris; Study Director: Jessie Aouizerate, MD, Assistance Publique - Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: June 23, 2011
• First Submitted That Met QC Criteria: August 18, 2011
• First Posted (Estimated): August 19, 2011

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Corticosteroids; Diet low in sugar and salt; Dermatological disease; Corticosteroids Allergy; 3 Months
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Skin and Connective Tissue Diseases; Asthma; Autoimmune Diseases; Skin Diseases; Health Care Quality, Access, and Evaluation; Therapeutics; Health Care Evaluation Mechanisms; Quality of Health Care; Epidemiologic Study Characteristics; Clinical Protocols
• Other Study ID Numbers: K080906; AFSSAPS (Other Identifier: 2010-A01439-30)