Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
Study NCT ID:
NCT03920150
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2019-04-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitamin D 24'000 IU for Oral Intermittent Supplementation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patient will be recruited by their general practitioner. Patients will be randomly assigned to be supplemented with monthly solution (control group), monthly capsules (IMP group) or weekly capsules after calculation of a individual loading dose (IMP + loading dose group).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-03', 'studyFirstSubmitDate': '2019-04-12', 'studyFirstSubmitQcDate': '2019-04-17', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum level of vitamin D', 'timeFrame': '3 months of treatment', 'description': 'Level of serum vitamin D after 3 month treatment compared to baseline value'}], 'secondaryOutcomes': [{'measure': 'Serum level of vitamin D after loading dose', 'timeFrame': 'up to 4 months of treatment', 'description': 'Level of serum vitamin D \\> 75 nmol/l after an individual number of treatment weeks, calculated with a loading dose formula.'}, {'measure': 'Adverse Drug Reactions', 'timeFrame': '3 months of treatment', 'description': 'Number and severity of adverse drug reactions during treatment'}, {'measure': 'Adherence to medication', 'timeFrame': '3 months of treatment', 'description': 'Taking adherence: (number of doses taken) divided by (number of doses prescribed) x 100.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['optimal vitamin D value'], 'conditions': ['Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': "Vitamin D deficiency (defined as 25(OH)-vitamin D serum level \\<50 nmol/l) is cured with oral supplementation. National guidelines recommend the administration of 800 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Cumulative intermittent administration monthly (24'000 IU) or weekly (5'600 IU) is possible. Commercially available intermittent pharmaceutical forms in Switzerland are liquid (oily or alcoholic solution). The study aims to compare the rise of vitamin D3 levels after treatment between newly developed soft capsules and monthly solution (primary outcome), and to evaluate the effect of a loading dose (without infringing the cumulative maximal dose of 4'000 IU per day) on the achievement of optimal values \\>75 nmol/l (secondary outcome). The investigators will use newly developed soft capsules and alcoholic solution, which are commercially available in Switzerland.", 'detailedDescription': "Group Control, Alcoholic Drinking Solution: 5 ml of an alcoholic drinking solution with 24'000 IU vitamin D p.o. once a month for 3 months (3 doses).\n\nGroup IMP, Capsules: one capsule with 24'000 IU vitamin D p.o. once a month for 3 months (3 doses).\n\nGroup IMP + loading dose, Loading Dose: one capsule with 24'000 IU vitamin D p.o. once a week during an individually calculated number of weeks.\n\nAll 3 groups: Measurement of vitamin D in serum before therapy and one week after the last dose."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* vitamin D deficiency by serum level \\<50 nmol/l\n\nExclusion Criteria:\n\n* hypercalcaemia'}, 'identificationModule': {'nctId': 'NCT03920150', 'acronym': 'DO-IT', 'briefTitle': "Vitamin D 24'000 IU for Oral Intermittent Supplementation", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': "Vitamin D 24'000 IU for Oral Intermittent Supplementation", 'orgStudyIdInfo': {'id': '2019-00987'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': "5 ml alcoholic solution containing 24'000 IU vitamin D for 3 months", 'interventionNames': ['Drug: Vitamin D3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IMP', 'description': "Vitamin D oily capsules containing 24'000 IU vitamin D for 3 months", 'interventionNames': ['Drug: Vitamin D oily capsules']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IMP + loading dose', 'description': "Vitamin D oily capsules containing 24'000 IU vitamin D for an individual number of weeks calculated with the formula: 40 x (100 - actual value \\[nmol/l\\] x body weight \\[kg\\] / 24'000 IU.", 'interventionNames': ['Drug: Vitamin D oily capsules']}], 'interventions': [{'name': 'Vitamin D3', 'type': 'DRUG', 'otherNames': ['Vi-De 3 Monatsdosis'], 'description': 'Patient will be treated with 3 doses of alcoholic solution for 3 months.', 'armGroupLabels': ['Control']}, {'name': 'Vitamin D oily capsules', 'type': 'DRUG', 'description': 'Patient will be treated with 3 capsules for 3 months.', 'armGroupLabels': ['IMP']}, {'name': 'Vitamin D oily capsules', 'type': 'DRUG', 'description': 'Patient will be treated with weekly capsules for an individually calculated number of weeks.', 'armGroupLabels': ['IMP + loading dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4056', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Pharmaceutical Care Research Group', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Kurt E Hersberger, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Pharmaceutical Care Research Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}