Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-29 @ 11:47 PM
Study NCT ID:
NCT03350568
Status:
COMPLETED
Last Update Posted:
2017-11-24
First Post:
2017-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Antioxidants and Chronic Diseases-The Swedish National March Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43880}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2010-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-22', 'studyFirstSubmitDate': '2017-11-19', 'studyFirstSubmitQcDate': '2017-11-19', 'lastUpdatePostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial Infarction', 'timeFrame': 'October 1, 1997-December 31, 2010', 'description': 'Based on ICD-10 I21'}, {'measure': 'Osteoarthritis', 'timeFrame': 'October 1, 1997-December 31, 2010', 'description': 'Based on ICD-10 M15-19'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antioxidants', 'Oxidative Stress', 'Atherosclerosis', 'Epidemiology'], 'conditions': ['Myocardial Infarction', 'Diet', 'Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Dietary antioxidants might protect from the development of chronic diseases by reducing levels of oxidative stress. The investigators therefore investigated the effect of dietary Non Enzymatic Antioxidant Capacity, which measures interactions between antioxidants in the whole diet, on the risk of 1) myocardial infarction and 2) osteoarthritis.', 'detailedDescription': 'Aim: Among an initial sample of 43,880 men and women who participated in the Swedish National March Cohort in 1997 the investigators aimed to investigate the effect of dietary Non Enzymatic Antioxidant Capacity (NEAC), assessed by a validated food frequency questionnaire at baseline, on the risk of 1) myocardial infarction and 2) osteoarthritis.\n\nIdentification of cases: Incident cases of myocardial infarction (ICD-10 code I21) and osteoarthritis (ICD-10 M15-19) were identified through exact linkages to the Swedish registries of population, migration, death, cancer, and inpatient care, using the national registration numbers as identifiers.\n\nMain methods: The investigators fitted Cox proportional hazards regression models with age as underlying time scale to estimate hazard ratios (HR) with 95% confidence intervals (95% CI) for each outcome of interest at different levels of dietary NEAC. The investigators fitted multiple imputation models based on chained equations to address missingness of confounder variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study 1: Study population (n=34,543) was between the age of 18-94 years and free from cancer (except non-melanoma skin cancer) or any cardiovascular disease before the beginning of follow up.\n\nStudy 2: Study population (n=29,188) was between the age of 40-94 years and free from osteoarthritis, bone cancer or -metastases , joint injury, or any arthropathy disease other than.', 'eligibilityCriteria': 'Exclusion Criteria Study 1:\n\n* Incorrect national registration number\n* Subjects who were \\<18 years\n* Emigration before beginning of follow-up\n* Death before beginning of follow-up\n* Cancer diagnosis\n* Any cardiovascular disease\n* Extreme energy intake\n\nExclusion Criteria Study 2:\n\n* Incorrect national registration number\n* Subjects who were \\<40 years\n* Emigration before beginning of follow-up\n* Death before beginning of follow-up\n* Osteoarthritis diagnosis\n* Bone cancer- or metastases\n* Joint injury or any arthropathy disease other than osteoarthritis\n* Extreme energy intake'}, 'identificationModule': {'nctId': 'NCT03350568', 'briefTitle': 'Dietary Antioxidants and Chronic Diseases-The Swedish National March Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Study 1: Dietary Non Enzymatic Antioxidant Capacity and the Risk of Myocardial Infarction - The Swedish National March Cohort; Study 2: Dietary Total Antioxidant Capacity and Risk of Osteoarthritis in the Swedish National March Cohort', 'orgStudyIdInfo': {'id': '97-205'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Total dietary NEAC assessed at baseline', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Ylva Trolle Lagerros, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine, Clinical Epidemiology, Karolinska Institutet; Department of Medicine, Clinic of Endocrinology, Karolinska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Associate Professor', 'investigatorFullName': 'Ylva Trolle Lagerros', 'investigatorAffiliation': 'Karolinska Institutet'}}}}