Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-04-17 @ 10:45 PM
Study NCT ID:
NCT02664857
Status:
COMPLETED
Last Update Posted:
2021-04-21
First Post:
2016-01-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D Supplementations and Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-20', 'studyFirstSubmitDate': '2016-01-20', 'studyFirstSubmitQcDate': '2016-01-22', 'lastUpdatePostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Non-communicating Children's Pain Checklist - Postoperative Version", 'timeFrame': 'At Postoperative period for first 1 hour', 'description': 'The subjects will evaluate per 15 minutes for 1 hour.'}], 'secondaryOutcomes': [{'measure': 'vitamin D level', 'timeFrame': 'At first day and end of the 12 weeks', 'description': 'Serum vitamin D level will evaluate At first day and end of the 12 weeks.'}, {'measure': 'Postoperative sedation-agitation', 'timeFrame': 'At postoperative first hour', 'description': 'At postoperative period, every 15 minutes up to 1 hour. Ramsey sedation scores will record.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vitamin D', 'Postoperative Pain', 'Mental Motor Retardation'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'In this study, effect of vitamin D supplementation on postoperative pain and sedation-agitation will investigate. Children with mental motor retardation between 7-17 age which dental treatment will be performed under general anaesthesia will be included in this study. 600 IU vitamin D will apply to group D per orally during 12 weeks. Group P will not take anything during 12 weeks. At first day and end of the 12 weeks, serum vitamin D, calcium level will evaluate. At the end of the 12 weeks general anaesthesia will be performed for teeth check up, flouring, scaling polishing, tooth extraction, filling applications, amputations, root canal treatment. After then postoperative pain, sedation and agitation will be evaluate. All data will be statistically evaluate at the end of the study.', 'detailedDescription': "Vitamin D deficiency could seem in children with mental and motor retardation. Some researches show that vitamin D supplementations can reduce pain. In this study, the researchers aimed to show effect of vitamin D supplementation on postoperative pain and sedation-agitation. These children which will be applied dental treatment under general anaesthesia included in this study. All subjects randomly divided to the two groups. Every group will include 30 subject. Group D included mentally retarded children which will take daily 600 IU orally vitamin D supplementation during 12 weeks. In the other group(group P) mentally retarded children will not take any supplementation during 12 week. At the first day and last day(after 12 weeks) of study, blood sample will take from all subject. Serum vitamin D, calcium level will evaluate in this sample at the end of the study. All samples will be frozen and stored until testing. All children will be operated under general anaesthesia. Propofol 2mg/kg, rocuronium 0,6 mg/kg will apply for anaesthesia induction. Anaesthesia will maintain with sevoflurane and oxygen- nitrous oxide mixture. Non-communicating Children's Pain Check-list and Ramsey sedation scale will apply all children after postoperative care unit. All children will be evaluate every 15 minutes. After data collection, all data will be analysed with statistically."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mentally and motor retarded children\n* dental treatment under general anaesthesia\n\nExclusion Criteria:\n\n* normally children(not MMR)\n* The persons who not accept the including study'}, 'identificationModule': {'nctId': 'NCT02664857', 'briefTitle': 'Vitamin D Supplementations and Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'Effect of Vitamin D Supplementation on Postoperative Pain and Sedation-agitation', 'orgStudyIdInfo': {'id': 'Vitamin D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'vitamin D', 'description': 'After per orally vitamin D supplementation during 12 weeks, serum Vitamin D level will evaluate with laboratory testing. 600 IU vitamin D will apply to 30 subject during 12 weeks. At first day end end of the 12 weeks serum vitamin D level will analyse with laboratory testing.End of the 12 weeks, the children will be perform dental treatment under general anaesthesia. Postoperative pain, anxiety and sedation will evaluate.', 'interventionNames': ['Drug: Vitamin D']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo', 'description': 'Grup P will not take vitamin D during 12 weeks. This group just only will follow by researchers.At first day end end of the 12 weeks serum vitamin D level will analyse with laboratory testing.End of the 12 weeks, the children will be perform dental treatment under general anaesthesia. Postoperative pain, anxiety and sedation will evaluate.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'otherNames': ['vitamin D supplementation'], 'description': 'Group D will take 600 IU vitamin D per orally during 12 weeks. At first day and end of the 12 weeks serum vitamin D level will analyse with laboratory testing', 'armGroupLabels': ['vitamin D']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Observed group'], 'description': 'Group P will not take orally during 12 weeks. This group will only observe by researchers.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01380', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Cukurova University', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}], 'overallOfficials': [{'name': 'Dilek Ozcengiz, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Cokurova University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'ebru biricik', 'investigatorAffiliation': 'Cukurova University'}}}}