Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-01-08 @ 6:29 PM
Study NCT ID:
NCT01420133
Status:
COMPLETED
Last Update Posted:
2015-12-22
First Post:
2011-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is a Diet Necessary When Corticosteroid Treatment is Prescribed?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D012871', 'term': 'Skin Diseases'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002985', 'term': 'Clinical Protocols'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-21', 'studyFirstSubmitDate': '2011-06-23', 'studyFirstSubmitQcDate': '2011-08-18', 'lastUpdatePostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative number of clinical events recorded during the study, per randomization group', 'timeFrame': '24 months', 'description': 'Cumulative number of the following clinical events recorded during the study, per randomization group:\n\n* Weight gain between study entry and the end of it\n* Significant rise in blood pressure between study entry and the end of it\n* 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\n* Occurrence of heart failure'}, {'measure': 'Observance of the diet low in salt and sugar will be estimated by patient questionnaire and diary', 'timeFrame': '12 months'}, {'measure': 'Tolerance of the diet low in salt and sugar will be estimated by patient questionnaire and diary', 'timeFrame': '12 months'}, {'measure': 'Observance of the diet low in salt and sugar will be estimated by patient questionnaire and diary', 'timeFrame': '6 months'}, {'measure': 'Tolerance of the diet low in salt and sugar will be estimated by patient questionnaire and diary', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Sides effects of corticosteroids therapy', 'timeFrame': '24 months', 'description': 'frequency of sides effects'}, {'measure': 'Impaired glucide metabolism', 'timeFrame': '24 months', 'description': 'surveillance of creatininemia, urinary and serum electrolytes changes\n\n* Glucose regulation change observed by blood glucose, insulin, QUICKI and OGTT tests performed at the beginning and the end of the study.\n* Evaluation of the pancreatic beta cell function (HOMA-B%) estimated as Matthews et al., 1985 done.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Corticosteroids', 'Diet low in sugar and salt', 'Dermatological disease', 'Corticosteroids Allergy', '3 Months'], 'conditions': ['Autoimmune Diseases', 'Asthma']}, 'descriptionModule': {'briefSummary': 'Few recommendations concerning the diet and dosage to be administered to patients treated with corticosteroids are established.\n\nIt 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.', 'detailedDescription': '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.\n\nHowever, 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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria :\n\n* Age \\> 18 years\n* All patients for whom corticoids initially prescribed at a dose \\> 20 mg per 24 hours, during a period of 3 months minimum\n* 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)\n* 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.\n* Time between first corticoids delivery and randomization \\< 1 month\n* Patient who gave his non-opposition\n\nNote: Depending on their health condition, patient may receive one or more intravenous injections of methylprednisolone (until 3 injections), before the beginning of oral corticotherapy.\n\nExclusion criteria :\n\n* Age \\< 18 years or whose disability warrants a guardianship\n* All patients for whom corticoids prescribed \\<20 mg per 24 hours or for an expected period \\<3 months\n* Intramuscular or intravenous sequential corticoids delivery, without associated per os corticoids.\n* Any corticotherapies other than prednisone, prednisolone or methylprednisolone.\n* Any corticotherapies with alternating doses\n* Intravenous or intramuscular injection corticotherapy\n* Patient who received corticoids at a dose \\>20 mg / day, during 3 last years\n* Allergy, hypersensitivity or cons-indication to corticoids\n* The existence of diabetes before corticotherapy, because pre-existing diabetes requires specific follow-up treatment, such as sugars restrictions\n* Uncontrolled hypertension (SBP ≥ 180mHg or DBP ≥ 110mHg)'}, 'identificationModule': {'nctId': 'NCT01420133', 'acronym': 'Cortisel', 'briefTitle': 'Is a Diet Necessary When Corticosteroid Treatment is Prescribed?', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Is a Low Salt Diet and Low Sugar Content Necessary When Corticosteroid Treatment is Prescribed?', 'orgStudyIdInfo': {'id': 'K080906'}, 'secondaryIdInfos': [{'id': 'AFSSAPS', 'type': 'OTHER', 'domain': '2010-A01439-30'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal regimen', 'description': 'without special regimen for corticosteroid therapy', 'interventionNames': ['Other: Regimen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard arm', 'description': 'with diet low in salt and sugar', 'interventionNames': ['Other: Standard regimen']}], 'interventions': [{'name': 'Regimen', 'type': 'OTHER', 'description': 'regimen normal in salt and sugar', 'armGroupLabels': ['Normal regimen']}, {'name': 'Standard regimen', 'type': 'OTHER', 'description': 'with diet low in salt and sugar', 'armGroupLabels': ['Standard arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Cochin Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Loic Guillevin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Jessie Aouizerate, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}