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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Autoimmune Diseases; Asthma	Other: Regimen; Other: Standard regimen	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Official Title:	Is a Low Salt Diet and Low Sugar Content Necessary When Corticosteroid Treatment is Prescribed?
Study Start Date :	November 2011
Actual Primary Completion Date :	October 2015
Actual Study Completion Date :	October 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Cumulative number of clinical events recorded during the study, per randomization group [ Time Frame: 24 months ]

   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
2. Observance of the diet low in salt and sugar will be estimated by patient questionnaire and diary [ Time Frame: 12 months ]
3. Tolerance of the diet low in salt and sugar will be estimated by patient questionnaire and diary [ Time Frame: 12 months ]
4. Observance of the diet low in salt and sugar will be estimated by patient questionnaire and diary [ Time Frame: 6 months ]
5. Tolerance of the diet low in salt and sugar will be estimated by patient questionnaire and diary [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. Sides effects of corticosteroids therapy [ Time Frame: 24 months ]
   frequency of sides effects
2. Impaired glucide metabolism [ Time Frame: 24 months ]

   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
Cochin Hospital
Paris, France, 75014

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:	Loic Guillevin, MD, PhD	Assistance Publique - Hôpitaux de Paris
Study Director:	Jessie Aouizerate, MD	Assistance Publique - Hôpitaux de Paris

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT01420133 History of Changes
Other Study ID Numbers:	K080906; AFSSAPS ( Other Identifier: 2010-A01439-30 )
First Posted:	August 19, 2011
Last Update Posted:	December 22, 2015
Last Verified:	December 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:

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

Additional relevant MeSH terms:

Autoimmune Diseases; Immune System Diseases