Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT03403933
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2017-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitamin D Supplementation on in Major Orthopedic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2017-12-19', 'studyFirstSubmitQcDate': '2018-01-11', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of improvement of ejection fraction (FE)', 'timeFrame': '6 months', 'description': 'Evaluation of improvement of ejection fraction (FE) or longitudinal strain calculated by speckle tracking at 6 months in cardiopathic patients with vitamin D deficiency who underwent supplementation with calcifediol, during functional recovery after major orthopedic surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypovitaminosis D', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'Prospective, monocentric study in open, aimed at evaluating the effects of supplementation with calcifediol on left ventricular function parameters in cardiopathic subjects undergoing major orthopedic surgery.', 'detailedDescription': 'Population of the study: 47 cardiopathic patients with hypovitaminosis D supplemented with calcifediol to reach vitamin D levels\\> 30 ng / ml within 6 months. The purpose of this study is to evaluate the improvement of the ejection fraction or GLS (global longitudinal strain) calculated by speckle tracking at 6 months in cardiopathic patients with vitamin D deficiency during functional recovery after major orthopedic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: \\> or equal to 55 years, \\< or equal to 85 years\n* cardiopathic patients (including hypertension) who must undergo major orthopedic surgery at our site\n* patients with diagnosis: hypovitaminosis d\n\nExclusion Criteria:\n\n* presence of neoplasm\n* endocrinological pathologies excluding diabetes mellitus\n* advanced chronic renal failure (GFR \\< 35 ml/min)\n* pregnant women\n* impossibility to participate to the rehabilitation protocol or to perform the established controls'}, 'identificationModule': {'nctId': 'NCT03403933', 'briefTitle': 'Vitamin D Supplementation on in Major Orthopedic Surgery', 'organization': {'class': 'OTHER', 'fullName': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"}, 'officialTitle': 'Study of the Effect of Calcifediol Supplementation on Left Ventricular Function in Cardiopathic Patients Undergoing Major Orthopedic Surgery', 'orgStudyIdInfo': {'id': 'Vitamina D (PI: M Turiel)'}, 'secondaryIdInfos': [{'id': 'L4073', 'type': 'OTHER_GRANT', 'domain': 'Italian Ministry of Health'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cardiopathic patients in hypovitaminosis', 'description': 'Didrogyl 10 ml: 10 drops a day to obtain levels of vitamin D \\> 30 ng /ml. Once these values are obtained lower the dose to 4-5 drops a day, with the aim, however, of keeping the plasma values between 30 and 60 ng/ml during 6 months of the study', 'interventionNames': ['Drug: Didrogyl']}], 'interventions': [{'name': 'Didrogyl', 'type': 'DRUG', 'description': 'Calcifediol will be administered at a dose of 10 drops per day (as indicated for use) for 6 months or until vitamin D levels\\> 30 ng / ml are obtained.\n\nOnce these values have been obtained, the dosage can be reduced to a dosage of 4/5 drops of calcifediol (1 drop contains 5mcg of calcifediol) with the aim to maintain the plasma values of 25 (OH) D in a optimal range between 30-60 ng / ml during the 6 month of the duration of the study.', 'armGroupLabels': ['cardiopathic patients in hypovitaminosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Istituto Ortopedico Galeazzi', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Maurizio Turiel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Istituto Ortopedico Galeazzi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}