Is a Diet Necessary When Corticosteroid Treatment is Prescribed?

NCT01420133 | Completed DMC

• 2 other identifiers: K080906AFSSAPS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Autoimmune Diseases

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Sides effects of corticosteroids therapy

  24 months

• Impaired glucide metabolism

  24 months

Study Arms (2)

Normal regimen

EXPERIMENTAL

without special regimen for corticosteroid therapy

Other: Regimen

Standard arm

ACTIVE COMPARATOR

with diet low in salt and sugar

Other: Standard regimen

Interventions

Regimen OTHER

regimen normal in salt and sugar

Normal regimen

Standard regimen OTHER

with diet low in salt and sugar

Standard arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Cochin Hospital

Paris, 75014, France

Location

MeSH Terms

Conditions

Autoimmune Diseases; Asthma; Skin Diseases

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Loic Guillevin, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Jessie Aouizerate, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: August 19, 2011
• Study Start: November 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

FR (1)