Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT01480869
Status:
COMPLETED
Last Update Posted:
2019-09-10
First Post:
2011-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002118', 'term': 'Calcium'}, {'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-06', 'studyFirstSubmitDate': '2011-11-24', 'studyFirstSubmitQcDate': '2011-11-28', 'lastUpdatePostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the increase in normalization of serum vitamin D level', 'timeFrame': '6 months', 'description': 'To compare the increase in normalization of serum vitamin D level adjusted to baseline level in patients receiving either vitamin D supplementation tailored to vitamin D deficiency or conventional vitamin D supplementation.'}], 'secondaryOutcomes': [{'measure': 'Baseline vitamin D/calcium status in this patient population', 'timeFrame': 'Baseline'}, {'measure': 'Normalization rate of serum 25-OHD level', 'timeFrame': '12, 18 and 24 months'}, {'measure': 'Normalization rate of serum 25-OHD level in control patients who shift to experimental strategy', 'timeFrame': '6 months after crossover'}, {'measure': 'Clinical and biological tolerance profile', 'timeFrame': 'During treament administration (can last up to 24 months)', 'description': 'According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.0'}, {'measure': 'Treatment compliance', 'timeFrame': 'During treatment administration (can last up to 24 months)', 'description': 'Treatment compliance will be assessed using a patient record book'}, {'measure': 'Quality of life', 'timeFrame': '24 months', 'description': 'Quality of life is assessed using the EORTC QLQ-C30 questionnaire'}, {'measure': 'Impact of study treatments on bone and joint pains induced by aromatase inhibitors', 'timeFrame': 'During treatment administration (can last up to 24 months)'}, {'measure': 'Changes in vitamin and calcium biological markers', 'timeFrame': 'Up to 24 months'}, {'measure': 'Predictive value of individual biomarkers', 'timeFrame': 'Up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Vitamin D supplementation', 'in neoadjuvant', 'adjuvant setting'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '27029707', 'type': 'DERIVED', 'citation': "Jacot W, Firmin N, Roca L, Topart D, Gallet S, Durigova A, Mirr S, Abach L, Pouderoux S, D'Hondt V, Bleuse JP, Lamy PJ, Romieu G. Impact of a tailored oral vitamin D supplementation regimen on serum 25-hydroxyvitamin D levels in early breast cancer patients: a randomized phase III study. Ann Oncol. 2016 Jul;27(7):1235-41. doi: 10.1093/annonc/mdw145. Epub 2016 Mar 30."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare normalization of vitamin D serum level after 6 months of vitamin D supplementation adjusted to baseline vitamin D serum level vs.conventional vitamin D supplementation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast adenocarcinoma treated by neoadjuvant or adjuvant chemotherapy within 12 months prior to study enrollment\n* WHO performance status 0-1\n* Age ≥18 years old\n* Affiliation to a social security regime or beneficiary of equivalent social protection\n* Written informed consent provided before any study specific procedures\n\nComplementary inclusion criterion for randomization\n\n\\- Proved vitamin D deficiency as defined by serum vitamin D level lower than 30 ng/ml (75 nmol/L).\n\nExclusion Criteria:\n\n* Metastatic disease\n* History or presence of any other malignancy (except curatively treated nonmelanoma skin cancer or in situ cervix carcinoma) ………….\n\ntraités dans les 5 ans précédents.\n\n* Contraindication to calcium or cholecalciferol\n* Known severe hypersensitivity to vitamin D or to calcium supplementation or to one of the excipients.\n* Disease and/or medical conditions accompanied by hypercalcaemia and/or hypercalciuria\n* Calcium lithiasis and tissue calcification\n* Hypervitaminosis D\n* Presence of significant comorbidities:\n\n i) Uncontrolled endocrine disease ii) Known disorders of calcium phophorus laboratory testing iii) Proved osteopenia or osteoporosis requiring vitamin D and calcium supplements\n* Concomitant treatment with other experimental products or another vitamin D calcium treatment\n* Pregnancy, breastfeeding or of reproductive potential not using an effective contraceptive method\n* Legal inability or restricted legal ability. Medical or psychological conditions not allowing proper study completion or informed consent signature'}, 'identificationModule': {'nctId': 'NCT01480869', 'acronym': 'VITACAL', 'briefTitle': 'Study of Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': "Institut du Cancer de Montpellier - Val d'Aurelle"}, 'officialTitle': 'Randomized Phase III Trial Comparing Conventional Vitamin D Supplementation vs. Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients Treated by Neoadjuvant or Adjuvant Chemotherapy.', 'orgStudyIdInfo': {'id': 'VITACAL'}, 'secondaryIdInfos': [{'id': 'VA 2010/12', 'type': 'OTHER', 'domain': 'VA 2010/12'}, {'id': '2010-023459-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional vitamin D and calcium supplementation', 'description': 'Conventional vitamin D and calcium supplementation with 2 daily OROCAL VITAMINE D3® (500 mg calcium/200 IU cholecalciferol) tablets.', 'interventionNames': ['Drug: calcium and cholecalciferol']}, {'type': 'EXPERIMENTAL', 'label': 'vitamin D supplementation tailored to vitamin D deficiency', 'description': 'Conventional calcium supplementation with 2 daily OROCAL 500® (500 mg calcium) tablets to suck + vitamin D3 supplementation (UVÉDOSE®, cholecalciferol, 100 000 IU drinkable solution, 2 ml vial) whose schedule of administration depends on vitamin deficiency level:\n\n* 100 000 IU of vitamin D3 at D1, D15, D28 and D43 if 25OHD level \\< 10 ng/mL\n* 100 000 IU of vitamin D3 at D1, D15, D28 if 10 ng/mL ≤ 25OHD level \\< 20 ng/mL\n* 100 000 IU of vitamin D3 at D1 if 20 ng/mL ≤ 25OHD level \\< 30 ng/mL', 'interventionNames': ['Drug: calcium and cholecalciferol']}], 'interventions': [{'name': 'calcium and cholecalciferol', 'type': 'DRUG', 'description': 'Tablet to suck: calcium 500 mg bid, cholecalciferol 200 IU bid', 'armGroupLabels': ['Conventional vitamin D and calcium supplementation']}, {'name': 'calcium and cholecalciferol', 'type': 'DRUG', 'description': 'Tablet: calcium 500 mg bid + 2 ml drinkable solution cholecalciferol 100 000 IU whose schedule of administration depends on vitamin deficiency level:\n\n* 100 000 IU of vitamin D3 at D1, D15, D28 and D43 if 25-OHD level \\< 10 ng/mL\n* 100 000 IU of vitamin D3 at D1, D15, D28 if 10 ng/mL ≤ 25-OHD level \\< 20 ng/mL\n* 100 000 IU of vitamin D3 at D1 if 20 ng/mL ≤ 25-OHD level \\< 30 ng/mL', 'armGroupLabels': ['vitamin D supplementation tailored to vitamin D deficiency']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': "CRLC Val d'Aurelle-Paul Lamarque", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut du Cancer de Montpellier - Val d'Aurelle", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}