Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 6:06 AM
Study NCT ID:
NCT02365259
Status:
UNKNOWN
Last Update Posted:
2015-02-18
First Post:
2015-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phototherapy in Persons With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010789', 'term': 'Phototherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-10', 'studyFirstSubmitDate': '2015-02-02', 'studyFirstSubmitQcDate': '2015-02-10', 'lastUpdatePostDateStruct': {'date': '2015-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Serum Vitamin D at 4 and 8 weeks', 'timeFrame': '0, 4, and 8 weeks', 'description': 'Venous blood will be collected to quantify levels of circulating Vitamin D.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Walking Speed at 4 and 8 weeks', 'timeFrame': '0, 4, and 8 weeks', 'description': 'Participants will walking for 25-feet as fast, but safely, as possible on an instrumented gait mat for measuring gait speed.'}, {'measure': 'Change from Baseline in Cognitive Function at 4 and 8 weeks', 'timeFrame': '0, 4, and 8 weeks', 'description': 'Participants will complete neuropsychological assessments of processing speed and learning and memory.'}, {'measure': 'Change from Baseline in Mood State at 4 and 8 weeks', 'timeFrame': '0, 4, and 8 weeks', 'description': 'Participants will complete a 30-item self-report measure of overall mood.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The current study examines the effect of phototherapy equipped with Narrow Band UVB lamps on vitamin D production in persons with MS.', 'detailedDescription': 'Participants will be exposed to phototherapy according to the 2014 Guidelines issued by the American Academy of Dermatology 3 days per week over an 8-week period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female with multiple sclerosis\n\nExclusion Criteria:\n\n* Inability to stand still in a stabilized fashion without risk of falling for up to 6 minutes\n* Known medical history of calcium disorder or knowledge of high calcium levels\n* Known medical history of hyper-parathyroidism\n* Current supplementation with oral vitamin D\n* Known allergy to vitamin D\n* History of cancer of any type including but not limited to skin cancer\n* Obesity defined as BMI \\> 30\n* Known history of fat malabsorption conditions (i.e., steatorrhea)\n* Current use of anti-epileptic medication\n* Current use of glucocorticoids\n* Fitzpatrick skin types I and VI using the Fitzpatrick skin type analysis\n* Recent use of tanning facilities'}, 'identificationModule': {'nctId': 'NCT02365259', 'briefTitle': 'Phototherapy in Persons With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Urbana-Champaign'}, 'officialTitle': 'Effect of UVB Phototherapy on Serum Vitamin D in Persons With Multiple Sclerosis; a Placebo Controlled Study', 'orgStudyIdInfo': {'id': '15178'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phototherapy', 'description': 'This arm involves exposure to a UVB phototherapy device 3 times per week over 8 weeks.', 'interventionNames': ['Device: Phototherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Shame phototherapy', 'description': 'This arm is identical with experimental arm, except that participants will be exposed to non-UVB florescent light.', 'interventionNames': ['Device: Phototherapy']}], 'interventions': [{'name': 'Phototherapy', 'type': 'DEVICE', 'description': 'Participants will be exposed to phototherapy according to the 2014 Guidelines issued by the American Academy of Dermatology 3 days per week over an 8-week period.', 'armGroupLabels': ['Phototherapy', 'Shame phototherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Exercise Neuroscience Research Laboratory', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}], 'overallOfficials': [{'name': 'Robert W Motl, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Urbana-Champaign'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Urbana-Champaign', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}