Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-29 @ 5:54 PM
Study NCT ID:
NCT06338059
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D014806', 'term': 'Vitamin B 12 Deficiency'}, {'id': 'D065134', 'term': 'Lipedema'}], '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'}, {'id': 'D014804', 'term': 'Vitamin B Deficiency'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-23', 'studyFirstSubmitDate': '2024-03-23', 'studyFirstSubmitQcDate': '2024-03-23', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vitamin B12 Level', 'timeFrame': '1 day', 'description': "Laboratory measurement of patient's vitamin B12 level in unit of pg/mL"}, {'measure': '25 OH Vitamin D Level', 'timeFrame': '1 day', 'description': "Laboratory measurement of patient's 25 OH vitamin D level in unit of ng/dl"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin D, B12 Deficiency Vitamin,Lipedema,Pain'], 'conditions': ['Vitamin D Deficiency', 'B12 Deficiency Vitamin', 'Lipedema']}, 'referencesModule': {'references': [{'pmid': '36551837', 'type': 'RESULT', 'citation': 'Poojari A, Dev K, Rabiee A. Lipedema: Insights into Morphology, Pathophysiology, and Challenges. Biomedicines. 2022 Nov 30;10(12):3081. doi: 10.3390/biomedicines10123081.'}, {'pmid': '16493517', 'type': 'RESULT', 'citation': 'Kiraly SJ, Kiraly MA, Hawe RD, Makhani N. Vitamin D as a neuroactive substance: review. ScientificWorldJournal. 2006 Jan 26;6:125-39. doi: 10.1100/tsw.2006.25.'}, {'pmid': '36045399', 'type': 'RESULT', 'citation': 'Gharibpoor F, Ghavidel-Parsa B, Sattari N, Bidari A, Nejatifar F, Montazeri A. Effect of vitamin B12 on the symptom severity and psychological profile of fibromyalgia patients; a prospective pre-post study. BMC Rheumatol. 2022 Sep 1;6(1):51. doi: 10.1186/s41927-022-00282-y.'}]}, 'descriptionModule': {'briefSummary': 'Lipedema is a disease characterized by bilateral abnormal fat deposition in the upper and lower extremities. Pain is a common symptom in lipedema.Vitamin D plays an important role in chronic pain. Vitamin B have analgesic role in some neuropathic pain conditions.This study aimedto evaluate the relationship between vitamin D and vitamin B12 levels and neuropathic pain in lipedema.', 'detailedDescription': "In this cross sectional study 200 lipedema patients will beincluded. According to painDETECT questionnaire scores of cases with lipedema patients will be divided into two groups;An overall score of \\> 13 likely or possible neuropathic pain (group 1) and \\<13 unlikely NP (group 2). Patients' age, gender, comorbid diseases and laboratory values (25 OH vitamin D and vitamin B12 levels) will be recorded."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'lipedema patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients diagnosed byan experienced physical medicine and rehabilitation specialist for the diagnosis of lipedema\n\nExclusion Criteria:\n\n* individuals who did not have 25(OH)D and B12 values in the past 6 months,\n* those with a history of gastrectomy or bypass surgery,\n* those consuming a vegetarian diet, those with lymphedema or chronic venous insufficiency, endocrine diseases, rheumatic diseases, malignancy, neurological diseases, and musculoskeletaldiseases that can be related to lower extremity neuropathic or nociceptivepain.'}, 'identificationModule': {'nctId': 'NCT06338059', 'briefTitle': 'Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema', 'organization': {'class': 'OTHER', 'fullName': 'Fatih Sultan Mehmet Training and Research Hospital'}, 'officialTitle': 'Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema:Cross Sectional Study', 'orgStudyIdInfo': {'id': 'Gulcanozturkchatipchousein'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'painDETECT questionnaire scores> 13 likely or possible neuropathic pain (group 1)', 'description': 'lipedema patients showing NP symptoms', 'interventionNames': ['Other: Vitamin B12 Level']}, {'label': 'painDETECT questionnaire scores13 unlikely neuropathic pain(group 2)', 'description': 'lipedema patients showing no NP symptoms', 'interventionNames': ['Other: Vitamin B12 Level']}], 'interventions': [{'name': 'Vitamin B12 Level', 'type': 'OTHER', 'otherNames': ['25 OH Vitamin D Level'], 'description': "Vitamin B12 Level Laboratory measurement of patient's vitamin B12 level in unit of pg/mL 25 OH Vitamin D Level Laboratory measurement of patient's 25 OH vitamin D level in unit of ng/dl", 'armGroupLabels': ['painDETECT questionnaire scores13 unlikely neuropathic pain(group 2)', 'painDETECT questionnaire scores> 13 likely or possible neuropathic pain (group 1)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34752', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Gulcan Ozturk', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatih Sultan Mehmet Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}