Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:36 PM
Study NCT ID:
NCT07435935
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Myoregulation Reflex and Postural Control in Vitamin D Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-21', 'studyFirstSubmitDate': '2026-02-21', 'studyFirstSubmitQcDate': '2026-02-21', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postural Stability Parameters', 'timeFrame': 'Single assessment session (baseline)', 'description': 'Postural stability parameters measured during single-leg and double-leg standing using force platform and surface electromyography, including postural sway and neuromuscular response variables.'}], 'secondaryOutcomes': [{'measure': 'Neuromuscular Reflex and Muscle Activation Patterns', 'timeFrame': 'Single assessment session (baseline)', 'description': 'Surface electromyography-derived muscle activation and reflex modulation parameters recorded under different loading and vibration conditions.'}, {'measure': 'Effect of Loading and Vibration on Postural Control', 'timeFrame': 'Single assessment session (baseline)', 'description': 'Changes in postural stability and neuromuscular responses under loaded and unloaded conditions with and without vibration.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin D Deficiency', 'Postural Stability', 'Balance Control', 'Neuromuscular Control', 'Surface Electromyography', 'Reflex Modulation', 'Bone Myoregulation Reflex', 'Standing Balance', 'Rehabilitation Research', 'Postural Sway'], 'conditions': ['Vitamin D Deficiency']}, 'referencesModule': {'references': [{'pmid': '25100978', 'type': 'RESULT', 'citation': 'Karacan I, Cakar HI, Sebik O, Yilmaz G, Cidem M, Kara S, Turker KS. A new method to determine reflex latency induced by high rate stimulation of the nervous system. Front Hum Neurosci. 2014 Jul 18;8:536. doi: 10.3389/fnhum.2014.00536. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'This observational study aims to investigate the relationship between vitamin D deficiency, postural stability, and neuromuscular control mechanisms in adults. The study will compare individuals with vitamin D deficiency and healthy controls.\n\nParticipants will undergo a single-session evaluation including surface electromyography and postural stability assessments during standing tasks under different loading and vibration conditions. No invasive procedures, medications, or blood sampling will be performed. Previously obtained routine laboratory results will be used for vitamin D status.\n\nThe study is designed to improve understanding of neuromuscular responses associated with vitamin D deficiency and to contribute to future rehabilitation strategies.', 'detailedDescription': 'This single-center observational study is designed to evaluate postural stability and load-sensitive neuromuscular control mechanisms in adults with vitamin D deficiency.\n\nParticipants will be divided into two groups based on their vitamin D status: individuals with vitamin D deficiency and healthy controls. Vitamin D levels will be determined using previously obtained routine laboratory test results. No additional blood sampling will be performed for this study.\n\nAll participants will undergo a standardized assessment protocol in a single session. Surface electromyography will be used to record muscle activity during standing tasks under different postural and loading conditions. Measurements will be performed during single-leg and double-leg stance, with and without vibration stimulation. The procedures are non-invasive and do not involve any pharmacological intervention.\n\nPostural stability parameters and neuromuscular response variables will be analyzed and compared between groups. The primary objective is to identify potential differences in reflex modulation and postural control associated with vitamin D deficiency.\n\nThe study aims to provide objective data on neuromuscular adaptations related to vitamin D status and to support future research in rehabilitation and balance training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults aged 20 to 40 years recruited from the outpatient clinics of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. Participants will include individuals with laboratory-confirmed vitamin D deficiency and healthy volunteers with normal vitamin D status.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20 to 40 years.\n* Ability to provide written informed consent.\n* Vitamin D deficiency group: serum 25-hydroxyvitamin D level \\<10 ng/mL measured within the last 3 months (routine clinical testing).\n* Healthy control group: normal vitamin D status based on routine clinical testing within the last 3 months.\n* No use of vitamin D or calcium supplementation within the last 3 months.\n\nExclusion Criteria:\n\n* Known metabolic bone disease other than vitamin D deficiency.\n* Neurological disorder (central or peripheral) or neuromuscular disease.\n* History of lower-limb surgery, fracture, or prosthesis affecting standing balance.\n* Vestibular disorder.\n* BMI \\>30 kg/m2.\n* Active malignancy.\n* Severe psychiatric disorder.\n* Skin condition preventing placement of surface EMG electrodes.'}, 'identificationModule': {'nctId': 'NCT07435935', 'acronym': 'BMR-VITD', 'briefTitle': 'Bone Myoregulation Reflex and Postural Control in Vitamin D Deficiency', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}, 'officialTitle': 'Investigation of Postural Stability and Load-Sensitive Neuromuscular Control Mechanisms in Vitamin D Deficiency', 'orgStudyIdInfo': {'id': 'OSTEOMALACIA-BMR-2026'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vitamin D Deficiency Group', 'description': 'Participants with laboratory-confirmed vitamin D deficiency based on routine clinical test results. All participants will undergo standardized non-invasive postural stability and surface electromyography assessments in a single session.'}, {'label': 'Healthy Control Group', 'description': 'Participants with normal vitamin D status based on routine clinical test results and no history of balance or neuromuscular disorders. All participants will undergo standardized non-invasive postural stability and surface electromyography assessments in a single session.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34186', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Physical Medicine and Rehabilitation Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Selim Sezikli, MD', 'role': 'CONTACT', 'email': 'selimsezikli@hotmail.com', 'phone': '+905065101833'}, {'name': 'Ilhan Karacan, Prof.', 'role': 'CONTACT', 'email': 'mdkaracanilhan@gmail.com', 'phone': '+905327005361'}], 'overallOfficials': [{'name': 'Selim Sezikli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Physical Medicine and Rehabilitation Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Supporting documents and de-identified individual participant data will be made available upon reasonable request after publication of the main results. Requests will be reviewed by the principal investigator and shared for academic purposes under a data use agreement.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data will be shared upon reasonable request for academic and research purposes, after publication of the main results. Requests will be reviewed by the principal investigator and data will be provided under a data use agreement.', 'accessCriteria': 'Access to de-identified individual participant data and supporting documents (study protocol, statistical analysis plan, and informed consent form) will be granted to qualified researchers upon reasonable request for academic and non-commercial purposes. Requests will be reviewed by the principal investigator. Data will be shared through secure electronic transfer under a data use agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist in Physical Medicine and Rehabilitation', 'investigatorFullName': 'Selim Sezikli', 'investigatorAffiliation': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}}}}