Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-02-25 @ 8:16 PM
Study NCT ID:
NCT02031692
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2014-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Vitamin D and Calcium Supplementation on the Prevention of Recurrences in BPPV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065635', 'term': 'Benign Paroxysmal Positional Vertigo'}], 'ancestors': [{'id': 'D014717', 'term': 'Vertigo'}, {'id': 'D015837', 'term': 'Vestibular Diseases'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D002118', 'term': 'Calcium'}, {'id': 'D002119', 'term': 'Calcium Carbonate'}], 'ancestors': [{'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'}, {'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': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1050}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-14', 'studyFirstSubmitDate': '2014-01-08', 'studyFirstSubmitQcDate': '2014-01-08', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence frequency of benign paroxysmal positional vertigo', 'timeFrame': 'Up to 1 year', 'description': 'The intervention group will receive tablets containing 400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate twice daily (CAVID CHEWABLE TAB, Takeda Pharmaceuticals) for 12 months when the initial serum vitamin D is decreased. The compliance will be determined by the percentage of consumed tablets from the delivered tablets during the follow-up period. Discontinuation of the supplementation due to adverse effects or other reasons will be registered using the telephone interview together with the primary outcome date. Participants in the control group will not have any intervention or placebo. They will not be allowed to take vitamin D or calcium as supplements during the follow-up. The primary outcome measure is the recurrence of BPPV after one year. Data on recurrences will be collected using a monthly telephone interview, and the patients will be asked to visit the clinic whenever they have the symptoms of BPPV. All the recurrences of BPPV will be included.'}], 'secondaryOutcomes': [{'measure': 'Changes in serum 25-hydroxy vitamin D level', 'timeFrame': 'Up to 1 year', 'description': 'In intervention group, the baseline vitamin D status of participants will be checked. And the level of 25-hydroxyvitamin D level will be rechecked at 2 months from the recruitment and at the end of the follow-up.'}, {'measure': 'Falling frequency', 'timeFrame': 'Up to year', 'description': 'To determine the supplementation of the vitamin D and calcium carbonate is effective to decrease falling frequency.'}, {'measure': 'Fracture frequency', 'timeFrame': 'Up to 1 year', 'description': 'To determine the supplementation of the vitamin D and calcium carbonate is effective to decrease fracture frequency.'}, {'measure': 'Quality of life', 'timeFrame': 'Up to 1 year', 'description': 'To determine the supplementation of the vitamin D and calcium carbonate is related to quality of life using UCLA-dizziness questionnaire'}, {'measure': 'Recurrence rate of benign paroxysmal positional vertigo', 'timeFrame': 'Up to 1 year', 'description': 'The intervention group will receive tablets containing 400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate twice daily (CAVID CHEWABLE TAB, Takeda Pharmaceuticals) for 12 months when the initial serum vitamin D is decreased. The compliance will be determined by the percentage of consumed tablets from the delivered tablets during the follow-up period. Discontinuation of the supplementation due to adverse effects or other reasons will be registered using the telephone interview together with the primary outcome date. Participants in the control group will not have any intervention or placebo. They will not be allowed to take vitamin D or calcium as supplements during the follow-up. The primary outcome measure is the recurrence rate of BPPV after one year. Data on recurrences will be collected using a monthly telephone interview, and the patients will be asked to visit the clinic whenever they have the symptoms of BPPV. All the recurrences of BPPV will be included.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Benign paroxysmal positional vertigo', 'Vitamin D', 'Calcium', 'Prevention'], 'conditions': ['Benign Paroxysmal Positional Vertigo']}, 'referencesModule': {'references': [{'pmid': '23096068', 'type': 'BACKGROUND', 'citation': 'Jeong SH, Kim JS, Shin JW, Kim S, Lee H, Lee AY, Kim JM, Jo H, Song J, Ghim Y. Decreased serum vitamin D in idiopathic benign paroxysmal positional vertigo. J Neurol. 2013 Mar;260(3):832-8. doi: 10.1007/s00415-012-6712-2. Epub 2012 Oct 25.'}, {'pmid': '19307540', 'type': 'BACKGROUND', 'citation': 'Jeong SH, Choi SH, Kim JY, Koo JW, Kim HJ, Kim JS. Osteopenia and osteoporosis in idiopathic benign positional vertigo. Neurology. 2009 Mar 24;72(12):1069-76. doi: 10.1212/01.wnl.0000345016.33983.e0.'}, {'pmid': '30883492', 'type': 'DERIVED', 'citation': 'Jeong SH, Kim JS. Impaired Calcium Metabolism in Benign Paroxysmal Positional Vertigo: A Topical Review. J Neurol Phys Ther. 2019 Apr;43 Suppl 2:S37-S41. doi: 10.1097/NPT.0000000000000273.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the supplementation of vitamin D and calcium prevents recurrences of benign paroxysmal positional vertigo in patients with vitamin D deficiency/insufficiency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years or older\n* brief episodes of vertigo induced by head motion\n* a typical positioning nystagmus characteristic of BPPV\n* no supplementation of vitamin D or calcium at the time of recruitment\n* informed consent to participate in this study\n* subject treated by repositioning maneuver\n\nExclusion Criteria:\n\n* other identifiable disorders of the central nervous system\n* supplementation of vitamin D or calcium at the time of recruitment\n* pregnancy\n* a history of an allergic reaction, or a medically significant adverse reaction to the investigational product\n* contraindication to cholecalciferol and calcium carbonate'}, 'identificationModule': {'nctId': 'NCT02031692', 'briefTitle': 'Efficacy of Vitamin D and Calcium Supplementation on the Prevention of Recurrences in BPPV', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Efficacy of Vitamin D and Calcium Supplementation on the Prevention of Recurrences in Benign Paroxysmal Positional Vertigo: A Prospective Multicenter Randomized Trial', 'orgStudyIdInfo': {'id': '08-2013-092'}, 'secondaryIdInfos': [{'id': 'HI10C2020', 'type': 'OTHER_GRANT', 'domain': 'Ministry of Health and Welfare'}, {'id': '1386-5650-7389-0156', 'type': 'OTHER', 'domain': 'Ministry of Food and Drug Safety, Korea'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D and calcium supplement', 'interventionNames': ['Drug: 400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': '400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate', 'type': 'DRUG', 'otherNames': ['CAVID CHEWABLE TAB, Takeda Pharmaceuticals'], 'description': 'The patients allocated to the intervention group will have a test for serum vitamin D, and receive 800 IU of vitamin D and 1000 mg of calcium as calcium carbonate when the serum vitamin D is decreased. The patients in the control group will be followed up without intervention for one year.', 'armGroupLabels': ['Vitamin D and calcium supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National Universtiy Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Ji-Soo Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Food and Drug Safety, Korea', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chairman, Department of Neurology', 'investigatorFullName': 'Ji-Soo Kim', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}