Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT02582892
Status:
COMPLETED
Last Update Posted:
2015-10-22
First Post:
2015-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systemic Vitamin D Supplementation in Dental Implants Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-21', 'studyFirstSubmitDate': '2015-10-20', 'studyFirstSubmitQcDate': '2015-10-20', 'lastUpdatePostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '25 OH Serum levels', 'timeFrame': '2 years', 'description': 'VIT D Serum levels'}], 'secondaryOutcomes': [{'measure': 'Osteoporosis condition', 'timeFrame': '2 years', 'description': 'Densitometry in patients femur bones'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '24519196', 'type': 'RESULT', 'citation': 'Botelho MA, Queiroz DB, Barros G, Guerreiro S, Fechine P, Umbelino S, Lyra A, Borges B, Freitas A, Queiroz DC, Ruela R, Almeida JG, Quintans L Jr. Nanostructured transdermal hormone replacement therapy for relieving menopausal symptoms: a confocal Raman spectroscopy study. Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01.'}, {'pmid': '20835566', 'type': 'RESULT', 'citation': 'Botelho MA, Martins JG, Ruela RS, Queiroz DB, Ruela WS. Nanotechnology in ligature-induced periodontitis: protective effect of a doxycycline gel with nanoparticules. J Appl Oral Sci. 2010 Jul-Aug;18(4):335-42. doi: 10.1590/s1678-77572010000400003.'}]}, 'descriptionModule': {'briefSummary': 'Vitamin D plays an essential role in calcium homeostasis and is critical for bone formation and remodeling.', 'detailedDescription': 'Evidence has demonstrated that vitamin D deficiency plays an important role in dental implants outcomes.\n\nLow serum levels of Vitamin D is considered as a risk factor, not only for low mineral bone density but also in other metabolic pathways such as those involved in immune response and chronic inflammatory diseases.\n\nThere are few studies demonstrating the role that vitamin D deficiency in the etiopathogenesis of oral diseases and the consequences in Dental Implants.\n\nDentists have not yet well understood the importance of a good bone metabolism response for a successful bone regeneration and osseointegration of implants.\n\nAn insufficient bone response can not guarantee the necessary stability of the implants placed in it, has been one of the biggest problems of implantology.\n\nThus, the aim of this study is to evaluate the efficacy of Systemic vitamin D supplementation in menopausal women cadidates for dental implants.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Menopause patients\n\nExclusion Criteria:\n\n* patients with a past history of neurological disorder;\n* who had received pharmacotherapy for depression within 8 weeks of screening;\n* who were taking medication known to interfere with Vit D;\n* who had recent psychiatricor systemic illness;\n* uncontrolled hypertension (blood pressure \\> 160/95mmHg);\n* unstable cardiovascular disease;\n* User of psychoactive medications;\n* alcohol excess consumption abuse.'}, 'identificationModule': {'nctId': 'NCT02582892', 'acronym': 'VitaminD', 'briefTitle': 'Systemic Vitamin D Supplementation in Dental Implants Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Potiguar'}, 'officialTitle': 'Systemic Vitamin D Supplementation in Menopausal Women With Dental Implants', 'orgStudyIdInfo': {'id': 'EVIDENCE x UNP VITAMIN D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Vit D', 'description': 'Vit D 20 mg/day', 'interventionNames': ['Drug: Vit D']}], 'interventions': [{'name': 'Vit D', 'type': 'DRUG', 'otherNames': ['Vitamin D'], 'description': '20 mg/day', 'armGroupLabels': ['Vit D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60115-191', 'city': 'Fortaleza', 'state': 'Ceará', 'country': 'Brazil', 'facility': 'Gynelogical Center', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'zip': '59060', 'city': 'Natal', 'state': 'Rio Grande do Norte', 'country': 'Brazil', 'facility': 'University Potiguar', 'geoPoint': {'lat': -5.795, 'lon': -35.20944}}, {'zip': '04023-062', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Marco Botelho', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Gugliemo G Campus, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Università degli Studi di Sassari'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Potiguar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Program Director of Graduate Biotechnology', 'investigatorFullName': 'MARCO BOTELHO', 'investigatorAffiliation': 'University Potiguar'}}}}