Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT02008760
Status:
UNKNOWN
Last Update Posted:
2013-12-11
First Post:
2013-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QOL, ADL and Pain Before and After Intervention With N3 From Krill With D3.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-10', 'studyFirstSubmitDate': '2013-12-07', 'studyFirstSubmitQcDate': '2013-12-10', 'lastUpdatePostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADL function on a scale 0-11', 'timeFrame': 'february 2013-february 2014'}, {'measure': 'pain on a scale 0-100 mm', 'timeFrame': 'february 2013-february 2014'}, {'measure': 'Quality of life on a scale 0-100', 'timeFrame': 'february 2013-february 2014'}], 'secondaryOutcomes': [{'measure': 'compliance in %', 'timeFrame': 'february 2013-february 2014'}, {'measure': 'changes at D3 levels', 'timeFrame': 'february 2013-february 2014'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pain', 'quality of life', 'ADL', 'DOLO test', 'compliance', 'D3'], 'conditions': ['Quality of Life', 'Pain']}, 'descriptionModule': {'briefSummary': "The aim of this project is investigation of patients' with chronic pain self-rated quality of life, ADL function and level of pain before and after 3 months of intervention with N-3 fatty acids from krill in combination with vitamin D3. Furthermore, the compliance of the patients and the effect of the intervention on the patients' vitamin D status and cardiovascular risk factors are studied."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 year +\n* can read and understand danish\n\nExclusion Criteria:\n\n* shellfish allergy\n* intake of anticoagulants and vitamin D\n* pacemaker\n* participating other studies'}, 'identificationModule': {'nctId': 'NCT02008760', 'briefTitle': 'QOL, ADL and Pain Before and After Intervention With N3 From Krill With D3.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hospitalet Valdemar'}, 'officialTitle': "Survey of Chronic Pain Patients' Self-rated Quality of Life, ADL Function and Pain Before and After Intervention With Omega 3 Fatty Acids From Krill With Vitamin D3", 'orgStudyIdInfo': {'id': 'SJ-327'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'vegetable oil with betacarotene', 'description': '4 capsules vegetable oil with betacarotene'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'krill and vitamin D3', 'description': 'krill and vitamin D3. (72 mg), four capsules daily', 'interventionNames': ['Dietary Supplement: Omega Krill with D3']}], 'interventions': [{'name': 'Omega Krill with D3', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['krill and vitamin D3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4100', 'city': 'Ringsted', 'country': 'Denmark', 'facility': 'Hospitalet Valdemar', 'geoPoint': {'lat': 55.4426, 'lon': 11.79011}}], 'overallOfficials': [{'name': 'Henrik Nielsen, C physician', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospitalet Valdemar'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospitalet Valdemar', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}