Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-09 @ 10:30 AM
Study NCT ID:
NCT03385356
Status:
COMPLETED
Last Update Posted:
2019-03-20
First Post:
2017-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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'}]}, '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1000 IU/day of Vitamin D vs 4000 IU of Vitamin D /day; IU (international units)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-18', 'studyFirstSubmitDate': '2017-12-20', 'studyFirstSubmitQcDate': '2017-12-20', 'lastUpdatePostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vitamin D supplementation dose response', 'timeFrame': '4 months', 'description': 'Change in vitamin D level in serum after supplementation with 1000IU/day or 4000 IU/day.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis, Relapsing-Remitting', 'Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': 'Vitamin D is important risk factor for developing multiple sclerosis (MS) and for disease progression. Patients with MS who had lower vitamin D levels were at increased risk for more clinical attacks and faster disease progression. It was also shown that patients with MS had lower vitamin D levels in serum than healthy controls. It is not clearly defined, which are the levels of vitamin D in serum, that are high enough to trigger immunomodulatory effect and are safe for patients.\n\nThis double-blind randomized clinical trial was designed to compare impact of vitamin D supplementation in two different doses (1000 IU/day vs 4000 IU/day) in patients with relapsing remitting MS. The main goal of this trial is to compare dose response on vitamin D supplementation and to estimate more closely appropriate level of vitamin D in serum which triggers some of experimentally shown immunomodulatory actions.', 'detailedDescription': 'Vitamin D is important risk factor for developing multiple sclerosis (MS) and for disease progression. Patients with MS who had lower vitamin D levels were at increased risk for more clinical attacks and faster disease progression. It was also shown that patients with MS had lower vitamin D levels in serum than healthy controls. It is not clearly defined, which are the levels of vitamin D in serum, that are high enough to trigger immunomodulatory effect and are safe for patients.\n\nThis double-blind randomized clinical trial was designed to compare impact of vitamin D supplementation during four months in winter time in two different doses (1000 IU/day vs 4000 IU/day) in patients with relapsing remitting MS. The main goal of this trial is to compare dose response on vitamin D supplementation and estimate more closely appropriate level of vitamin D in serum which triggers some of experimentally shown immunomodulatory actions. To define immunomodulatory response different laboratory, clinical and genetic tests will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Relapsing remitting MS\n* Treatment with immunomodulatory drug\n* Age 18-60 years and\n* EDSS (Expanded Disability Status Scale) score less than 5.\n\nExclusion Criteria:\n\n* Use of vitamin D supplements in the past 3 months\n* Pregnancy, planning pregnancy or nursing\n* Relapse of disease and corticosteroids use in past month\n* Active inflammation at the start of the study (flu, cystitis etc.)\n* Renal disease\n* Elevated levels of calcium or parathormone\n* Hypersensitivity to vitamin D preparations\n* Switching of immunomodulatory drug in past 3 months\n* Other autoimmune disease\n* History of hyperparathyroidism, liver disease, tuberculosis, sarcoidosis or kidney stones'}, 'identificationModule': {'nctId': 'NCT03385356', 'briefTitle': 'Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Maribor'}, 'officialTitle': 'Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis', 'orgStudyIdInfo': {'id': '38602SUN17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1000 IU of vitamin D per day', 'description': 'Half of randomized patients will receive 1000 IU of vitamin D per day', 'interventionNames': ['Drug: Vitamin D']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4000 IU of vitamin D per day', 'description': 'Half of randomized patients will receive 4000 IU of vitamin D per day', 'interventionNames': ['Drug: Vitamin D']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'otherNames': ['Oleovit D3'], 'description': 'Vitamin D supplementation of 1000IU vs 4000IU vitamin D per day for four months during winter time, when levels of vitamin D in serum of MS patients are especially low.', 'armGroupLabels': ['1000 IU of vitamin D per day', '4000 IU of vitamin D per day']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Maribor', 'country': 'Slovenia', 'facility': 'University Medical Centre Maribor', 'geoPoint': {'lat': 46.55583, 'lon': 15.64593}}], 'overallOfficials': [{'name': 'Saša Gselman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Centre Maribor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Maribor', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Faculty Maribor', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Saša Gselman, M.D.', 'investigatorAffiliation': 'University Medical Centre Maribor'}}}}