Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT05062018
Status:
UNKNOWN
Last Update Posted:
2022-12-06
First Post:
2021-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitamin D3 - Omega3 - Home Exercise - HeALTHy Aging and Longevity Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, serum, plasma, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 534}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-02', 'studyFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2021-09-20', 'lastUpdatePostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of functional decline', 'timeFrame': '24 months', 'description': 'assessed by short physical performance test battery'}, {'measure': 'Incidence of injurious falls', 'timeFrame': '24 months', 'description': 'assessed by fall questionnaire at each visit'}, {'measure': 'Incidence of high blood pressure', 'timeFrame': '24 months', 'description': 'Standardized blood pressure assessment in sitting position'}, {'measure': 'Incidence of cognitive decline', 'timeFrame': '24 months', 'description': 'assessed by Montreal Cognitive Assessment (MoCA)'}, {'measure': 'Incidence of infections', 'timeFrame': '24 months', 'description': 'assessed by infection questionnaire at each visit'}], 'secondaryOutcomes': [{'measure': 'Incidence and prevalence of frailty', 'timeFrame': '24 months', 'description': 'based on criteria by L. Fried (shrinking, weakness, poor endurance and energy, slowness, low physical activity level), SHARE-FI'}, {'measure': 'Incidence and prevalence of impaired mobility', 'timeFrame': '24 months', 'description': 'assessed by EQ5D-3L, physical activity questionnaire'}, {'measure': 'Incidence and prevalence of functional dependency', 'timeFrame': '24 months', 'description': 'assessed by PROMIS-HAQ'}, {'measure': 'Incidence and prevalence of anemia or iron deficiency', 'timeFrame': '24 months', 'description': 'assessed by blood markers (ferritin, soluble transferrin receptor, RBC, Hb, erythrocyte indices (MCV, MCH, MCHC), reticulocytes)'}, {'measure': 'Incidence and prevalence of any cardiovascular disease', 'timeFrame': '24 months', 'description': 'assessed by medical history'}, {'measure': 'Incidence and prevalence of heart arrhythmia', 'timeFrame': '24 months', 'description': 'assessed by ECG'}, {'measure': 'Incidence and prevalence of atrial fibrillation', 'timeFrame': '24 months', 'description': 'assessed by ECG'}, {'measure': 'Incidence and prevalence of heart failure, cardiomyopathy, heart valves abnormalities', 'timeFrame': '24 months', 'description': 'assessed by medical history, ECG, physical examination'}, {'measure': 'Incidence of stroke', 'timeFrame': '24 months', 'description': 'assessed by medical history'}, {'measure': 'Incidence and prevalence of Type 2 diabetes', 'timeFrame': '24 months', 'description': 'assessed by medical history'}, {'measure': 'Incidence and prevalence of dementia', 'timeFrame': '24 months', 'description': 'assessed by medical history'}, {'measure': 'Incidence and prevalence of osteoarthritis', 'timeFrame': '24 months', 'description': 'assessed by medical history'}, {'measure': 'Incidence and prevalence osteoporosis', 'timeFrame': '24 months', 'description': 'assessed by medical history'}, {'measure': 'Incidence and prevalence of sarcopenia, osteosarcopenia', 'timeFrame': '24 months', 'description': 'assessed by medical history'}, {'measure': 'Incidence and prevalence of any gastrointestinal disease', 'timeFrame': '24 months', 'description': 'assessed by medical history'}, {'measure': 'Incidence and prevalence of gastroesophageal reflux disease (GERD)', 'timeFrame': '24 months', 'description': 'assessed by medical history'}, {'measure': 'Incidence and prevalence of any micronutrient deficiency (Vitamins, Minerals and fatty acids)', 'timeFrame': '24 months', 'description': 'assessed by medical history'}, {'measure': 'Incidence and prevalence of knee buckling', 'timeFrame': '24 months', 'description': 'assessed by medical history, Buckling, KOOS, HOOS'}, {'measure': 'Incidence and prevalence of chronic pain', 'timeFrame': '24 months', 'description': 'assessed by medical history, McGill, Joint Map, EQ5D-3L'}, {'measure': 'Incidence and prevalence of subjective memory complaints', 'timeFrame': '24 months', 'description': 'assessed by medical history, MoCA, MACQ'}, {'measure': 'Incidence and prevalence of hearing impairment', 'timeFrame': '24 months', 'description': 'assessed by medical history, hearing test, physical examination'}, {'measure': 'Incidence and prevalence of depression', 'timeFrame': '24 months', 'description': 'assessed by medical history, GDS'}, {'measure': 'Incidence and prevalence insomnia', 'timeFrame': '24 months', 'description': 'assessed by medical history, Insomnia'}, {'measure': 'Incidence and prevalence of chronic inflammation', 'timeFrame': '24 months', 'description': 'assessed by medical history, blood marker (e.g. CRP)'}, {'measure': 'Incidence and prevalence of polypharmacy', 'timeFrame': '24 months', 'description': 'assessed by medication'}, {'measure': 'Incidence and prevalence of inappropriate medication prescription', 'timeFrame': '24 months', 'description': 'assessed by medication'}, {'measure': 'Incidence and prevalence of age related morbidity by individual drug use (e.g. Proton-Pump-Inhibitors, anticoagulants, benzodiazepines, antibiotics)', 'timeFrame': '24 months', 'description': 'assessed by medication'}, {'measure': 'Incidence and prevalence of malnutrition', 'timeFrame': '24 months', 'description': 'assessed by medical history, FFQ, GOHAI, Rome'}, {'measure': 'Incidence and prevalence of urinary incontinence', 'timeFrame': '24 months', 'description': 'assessed by medical history, IPPS, QUID'}, {'measure': 'Incidence and prevalence of impaired quality of life', 'timeFrame': '24 months', 'description': 'assessed by EQ5D-3L'}, {'measure': 'Incidence and prevalence of functional decline', 'timeFrame': '24 months', 'description': 'assessed by medical history'}, {'measure': 'Incidence of fractures', 'timeFrame': '24 months', 'description': 'assessed by fracture rate'}, {'measure': 'Incidence of all-cause hospitalization', 'timeFrame': '24 months', 'description': 'assessed by medical history'}, {'measure': 'Incidence and prevalence of frequent health care utilization', 'timeFrame': '24 months', 'description': 'assessed by medical history'}, {'measure': 'trajectories of frequent health care utilization', 'timeFrame': '24 months', 'description': 'assessed by medical history'}, {'measure': 'Incidence of nursing home placement', 'timeFrame': '24 months', 'description': 'assessed by medical history'}, {'measure': 'Incidence of cancer (any cancer, gastro-intestinal, breast cancer in women, prostate cancer in men)', 'timeFrame': '24 months', 'description': 'assessed by medical history'}, {'measure': 'Incidence of all-cause mortality', 'timeFrame': '24 months'}, {'measure': 'Prevalence of MIND diet adherence (DO-HEALTHcohort-MINDful substudy)', 'timeFrame': '24months', 'description': 'assessed by FFQ'}, {'measure': 'Prevalence and Incidence of Mild Cognitive impairment (DO-HEALTHcohort-MINDful substudy)', 'timeFrame': '24months', 'description': 'assessed by MoCA'}, {'measure': 'Dual-tasking gait variability (DO-HEALTHcohort-MINDful substudy)', 'timeFrame': 'one time', 'description': 'assessed by GAITRite® Platinum (Basel only)'}, {'measure': 'Prevalence of confirmed Covid-19 cases (DO-HEALTHcohort-MINDful substudy)', 'timeFrame': '24 months', 'description': 'assessed by medical history'}, {'measure': 'Prevalence of Covid-19 vaccinated participants (DO-HEALTHcohort-MINDful substudy)', 'timeFrame': '24 months', 'description': 'assessed by medical history'}, {'measure': 'Prevalence of reported subjective cognitive decline (DO-HEALTHcohort-MINDful substudy)', 'timeFrame': '24 months', 'description': 'assessed by MAC-Q, GDS, EQ5D-3L'}, {'measure': 'Covid-19 related resilience (DO-HEALTHcohort-MINDful substudy)', 'timeFrame': 'one time', 'description': 'assessed by Brief Resilience Scale (BRS)'}, {'measure': 'Covid-19 related stress (DO-HEALTHcohort-MINDful)', 'timeFrame': 'one time', 'description': 'assessed by Covid-19 Pandemic Stress Scale (CPSS)'}, {'measure': 'Covid-19 related coping behaviours (DO-HEALTHcohort-MINDful)', 'timeFrame': 'one time', 'description': 'assessed by Pandemic Coping Scale (PCS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Aging']}, 'descriptionModule': {'briefSummary': 'The DO-HEALTH trial will be extended into the cohort including the collection on life style factors such as diet, quality of life and physical activity, as well as health-related data on co-morbid conditions as well as a standardized assessment of multiple organ functions, physical, cognitive and mental function using surveys and standardized health assessments.', 'detailedDescription': 'The DO-HEALTH cohort will be a continuation of the trial without intervention and will elucidate longterm determinants of healthy, active and independent aging in European community-dwelling older adults. The main emphasize of the cohort will be to determine the risk factors, to quantify the incidence and to describe the trajectories of incident frailty, impaired mobility, loss of independence and age related morbidity (e.g. heart arrhythmia, type 2 diabetes, falls, fractures).\n\nAdditionally, the cohort will continue to investigate the primary endpoints of the original trial like the risk and incidence of injurious falls (bone); functional decline (muscle); high blood pressure (cardiovascular); cognitive decline (brain); and the rate of any infection (immunity). Moreover, the cohort will include and extend key secondary and exploratory endpoints of the original trial such as incidence and prevalence of anemia, sarcopenia, cardiovascular diseases, type 2 diabetes and cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The DO-HEALTH Cohort includes the population of the former DO-HEALTH clinical trial (NCT01745263)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Former participation in the DO-HEALTH clinical trial study\n\nExclusion Criteria:\n\n* Inability or unwillingness to give written informed consent\n* Medical condition that would make the results of the tests/assessments unreliable and/or would put too much burden to the participant, and/or leads to safety concerns.'}, 'identificationModule': {'nctId': 'NCT05062018', 'acronym': 'DO-HEALTH-C', 'briefTitle': 'Vitamin D3 - Omega3 - Home Exercise - HeALTHy Aging and Longevity Cohort', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Vitamin D3 - Omega3 - Home Exercise - HeALTHy Aging and Longevity Cohort', 'orgStudyIdInfo': {'id': '2019-00134'}}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Centre on Aging and Mobility, University of Zurich, City Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Heike Bischoff-Ferrari, Prof. Dr. med. DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heike Bischoff-Ferrari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. DrPH', 'investigatorFullName': 'Heike Bischoff-Ferrari', 'investigatorAffiliation': 'University of Zurich'}}}}