Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 9:05 AM
Study NCT ID:
NCT01695460
Status:
COMPLETED
Last Update Posted:
2015-12-29
First Post:
2012-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-28', 'studyFirstSubmitDate': '2012-09-25', 'studyFirstSubmitQcDate': '2012-09-26', 'lastUpdatePostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'Every 28 days', 'description': 'HIT-6 (Headache Impact Test)'}], 'primaryOutcomes': [{'measure': 'The number of migraine attacks', 'timeFrame': 'every 4 weeks', 'description': "The primary endpoint is the frequency of migraine attacks. This is estimated from the subjects' listing of attacks in the form of diaries. This is assessed as the number of migraine attacks per 4 weeks (28 days)."}], 'secondaryOutcomes': [{'measure': 'Evaluation of pain during migraine attacks', 'timeFrame': 'every 4 weeks', 'description': 'Evaluation of pain during migraine attacks carried out by the subjects themselves by completing diaries. The diaries trial participants evaluate the pain intensity during an attack using a 1-3 scale, where 1 is mild pain, 2 is moderate pain, and 3 severe pain.'}, {'measure': 'Hypersensitivity', 'timeFrame': 'Baseline and every 4 weeks', 'description': 'allodynia and hyperalgesia (hypersensitivity) assessed by standardized questions about the sensitivity of the skin associated with migraine.'}, {'measure': 'Migraine Symptoms', 'timeFrame': 'every 4 weeks', 'description': 'Migraine Symptoms, including aura, nausea, light and sound sensitivity are also assessed by trial participants using diaries.'}, {'measure': 'Quantitative Sensory Testing', 'timeFrame': 'Every 4 weeks', 'description': 'Pain Pressure Threshold and temporal summation are measured.'}, {'measure': 'Measuring levels of a biomarker. Changes in the levels of these biomarkers.', 'timeFrame': 'Baseline and after 6 months treatment (end of trial)', 'description': 'Changes in the levels of these biomarkers are measured:\n\n25(OH)D, 1,25(OH)D, GFAP, S100B, CGRP,Glutamate, Serotonin, Prostaglandin E2'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Migraine', 'Vitamin D'], 'conditions': ['Migraine According to International Headache Society (IHS) Criteria (ICHD-II)']}, 'referencesModule': {'references': [{'pmid': '30182753', 'type': 'DERIVED', 'citation': 'Gazerani P, Fuglsang R, Pedersen JG, Sorensen J, Kjeldsen JL, Yassin H, Nedergaard BS. A randomized, double-blinded, placebo-controlled, parallel trial of vitamin D3 supplementation in adult patients with migraine. Curr Med Res Opin. 2019 Apr;35(4):715-723. doi: 10.1080/03007995.2018.1519503. Epub 2018 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'The trial is primarily designed to investigate whether treatment with vitamin D may influence migraine in a placebo-controlled, blinded study. The hypothesis is that vitamin D may serve as a prophylactic treatment of migraine. The hypothesis is tested by examining the changes in the pain and symptom patterns associated with migraine by treatment with Vitamin D, by means of quantitative sensory testing, diaries and blood samples for measurement of vitamin D. Other pain biomarkers are also measured to evaluate whether the levels of these biomarkers in the blood is changed by the treatment with vitamin D. The hypothesis here is that levels of those biomarkers will change following the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women between 18 and 65, migraine must have occurred before the age of 50 years.\n* Diagnosed migraine according to International Headache Society (IHS) criteria (ICHD-II)\n\nExclusion Criteria:\n\n* Other neurological or neurodegenerative disorders\n* Medical conditions that may interfere with the result - violent head trauma, stroke, transient ischemic attacks\n* Musculoskeletal or mental illness\n* Addictive or previous addictive behavior defined as the abuse of cannabis, opioids or other drugs\n* Inability to cooperate\n* Pregnancy or breastfeeding, including women trying to conceive\n* Use of vitamin D supplementation\\> 10μg\n* In treatment with digoxin or thiazide\n* Patients with osteoarthritis, as they are taking or have taken vitamin D supplements\n* Patients with pre-existing hypercalcemia as vitamin D supplements are contraindicated in these patients'}, 'identificationModule': {'nctId': 'NCT01695460', 'briefTitle': 'A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University'}, 'officialTitle': 'A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine', 'orgStudyIdInfo': {'id': 'N-20120052'}, 'secondaryIdInfos': [{'id': 'Projekt #831302', 'type': 'OTHER_GRANT', 'domain': 'Det Frie Forskningsråd'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D', 'description': 'The active treatment consists of vitamin D and is given in tablets of the brand D3 Vitamin ®, supplied by D3 Pharmacy Ltd., Bispensgade 22, 9000 Aalborg.\n\nThe tablets contain the vitamin D in the form of vitamin D3, also known as cholecalciferol.\n\nD3 Vitamin ® consists of small white tablets, which are easy to swallow.\n\nD3 Vitamin ® contains 25 micrograms vitamin D3 (colecalciferol) per tablet, equivalent to 1000 IU (International Units).\n\nTablet Excipients: Cellulose, dicalcium phosphate, magnesium stearate, silicon dioxide and talc. Vitamin D3 ® contains no gluten, soy, gelatin or other animal products.', 'interventionNames': ['Drug: D3 Vitamin ®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablets to match D3 Vitamin ®, were produced. They are identical to the D3 Vitamin ® in appearance, ie small white tablets. These tablets do not have a therapeutic effect. Placebo tablets produced and delivered by D3 Pharmacy Ltd., Bispensgade 22, 9000 Aalborg.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'D3 Vitamin ®', 'type': 'DRUG', 'otherNames': ['D3 Vitamin ®, supplied by D3 Pharmacy Ltd'], 'description': 'Vitamin D and placebo supplied as tablets in containers of 124. The containers must be kept in dry and not too hot environment.\n\nAll subjects randomized to vitamin D, will receive 100 micrograms of vitamin D3/day, equivalent to 4000 IU. Vitamin D is administered orally 1 time a day with breakfast.', 'armGroupLabels': ['Vitamin D']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo tablets to match D3 Vitamin ®, produced by D3 Pharmacy Ltd'], 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'CCBR Aalborg A/S', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '9220', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg University', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Parisa Gazerani, Pharm D, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Aalborg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'CCBR Aalborg A/S, Aalborg, Denmark', 'class': 'UNKNOWN'}, {'name': 'Aalborg University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Pharm D, PhD', 'investigatorFullName': 'Parisa Gazerani', 'investigatorAffiliation': 'Aalborg University'}}}}