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| ID | Type | Description | Link |
|---|---|---|---|
| AFSSAPS | Other Identifier | 2010-A01439-30 |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal regimen | Experimental | without special regimen for corticosteroid therapy |
|
| Standard arm | Active Comparator | with diet low in salt and sugar |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regimen | Other | regimen normal in salt and sugar |
| |
| Standard regimen |
| 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:
| 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 |
| 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
|
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Inclusion criteria :
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 :
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| Name | Affiliation | Role |
|---|---|---|
| Loic Guillevin, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Jessie Aouizerate, MD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochin Hospital | Paris | 75014 | France |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D001249 | Asthma |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
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| ID | Term |
|---|---|
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| Other |
with diet low in salt and sugar |
|
| 24 months |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D017437 | Skin and Connective Tissue Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |