Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT07130305
Status:
RECRUITING
Last Update Posted:
2025-08-19
First Post:
2025-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
is There an Effect of Adding Body Vibration to Intake of Vitamin D on Some Outcomes of Familial Mediterranean Fever
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010505', 'term': 'Familial Mediterranean Fever'}], 'ancestors': [{'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2025-08-12', 'studyFirstSubmitQcDate': '2025-08-12', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bone mineral density', 'timeFrame': 'it will be measured after 6 months', 'description': 'it is a measure for bone density at 2-4 lumbar vertebrae'}], 'secondaryOutcomes': [{'measure': 'z score', 'timeFrame': 'it will be measured after 6 months', 'description': 'it is a score for measure for bone mass at 2-4 lumbar vertebrae'}, {'measure': 'vitamin D', 'timeFrame': 'it will be measured after 6 months', 'description': 'it will measured in plasma as serum 25-hydroxyvitamin D'}, {'measure': 'osteoprotegerin', 'timeFrame': 'it will be measured after 6 months', 'description': 'it will measured in plasma'}, {'measure': 'quadriceps torque', 'timeFrame': 'it will be measured after 6 months', 'description': 'it will measured in dominant side'}, {'measure': 'Standing long jump test', 'timeFrame': 'it will be measured after 6 months', 'description': 'it is an indicator for functional performance'}, {'measure': 'Thirty second sit to stand test', 'timeFrame': 'it will be measured after 6 months', 'description': 'it is an indicator for functional performance'}, {'measure': 'Ruffier index', 'timeFrame': 'it will be measured after 6 months', 'description': 'it is an indicator for cardiorespirtory fittness'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Familial Mediterranean Fever']}, 'descriptionModule': {'briefSummary': 'Familial mediterranean fever (FMF) is common in mediterranean region. this disorder is connected with deterioration in functional performance, fitness of cardiorespiration, muscle strength, and bone mass', 'detailedDescription': 'Familial mediterranean fever (FMF adolescent girls ) will be collected to be cateogarized to vibration group (vibration group) or control grouping. every group OF FMF will contain 20 FMF adolescent girls. both groups will receive vitamin D and their traditional colchicine doses daily for six months. vibration group will receive three sessions of 20-min whole body vibration in the week for 6 months'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'genderBased': True, 'genderDescription': 'based on self-representation of gender identity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFMF adolecent girls ages 13 -17 years forty patients\n\nExclusion Criteria:\n\ncardiac problems renal problems liver problems diabetes brain problems'}, 'identificationModule': {'nctId': 'NCT07130305', 'briefTitle': 'is There an Effect of Adding Body Vibration to Intake of Vitamin D on Some Outcomes of Familial Mediterranean Fever', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'is There an Effect of Addition of Body Vibration to Intake of Vitamin D on Some Outcomes of Familial Mediterranean Fever', 'orgStudyIdInfo': {'id': 'IRB00014233-33'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vibration group', 'description': 'vibration group OF FMF will contain 20 FMF adolescent girls. who will receive vitamin D and their traditional colchicine doses daily for six months. vibration group will receive also three sessions of 20-min whole body vibration in the week for 6 months', 'interventionNames': ['Other: whole body vibration plus usual care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'control group of Familial mediterranean fever (20 FMF adolescent girls ) will receive vitamin D and their traditional colchicine doses daily for six months.', 'interventionNames': ['Other: usual care']}], 'interventions': [{'name': 'whole body vibration plus usual care', 'type': 'OTHER', 'description': 'Familial mediterranean fever (20 FMF adolescent girls ) will be in this vibration group who will receive vitamin D and their traditional colchicine doses daily for six months. vibration group will also receive three sessions of 20-min whole body vibration in the week for 6 months', 'armGroupLabels': ['vibration group']}, {'name': 'usual care', 'type': 'OTHER', 'description': 'Familial mediterranean fever (20 FMF adolescent girls ) will be in this control group who will receive vitamin D and their traditional colchicine doses daily for six months.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'state': 'Dokki', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ali ismail, lecturer', 'role': 'CONTACT', 'email': 'ali.mohamed@pt.cu.edu.eg', 'phone': '02 01005154209'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Ali MA Ismail, lecturer', 'role': 'CONTACT', 'email': 'ali.mohamed@pt.cu.edu.eg', 'phone': '01005154209'}, {'name': 'Ali Ismail', 'role': 'CONTACT', 'email': 'allooka2012@gmail.com'}], 'overallOfficials': [{'name': 'Ali MA Ismail, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University', 'investigatorFullName': 'Ali Mohamed Ali ismail', 'investigatorAffiliation': 'Cairo University'}}}}