Clinical trial NCT05062018: Vitamin D3 - Omega3 - Home Exercise - HeALTHy Aging and Longevity Cohort
Official title: Vitamin D3 - Omega3 - Home Exercise - HeALTHy Aging and Longevity Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Aging
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 534
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The DO-HEALTH Cohort includes the population of the former DO-HEALTH clinical trial (NCT01745263)

Brief summary: 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.

Detailed description: 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).

Additionally, 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.

Eligibility criteria: Inclusion Criteria:

* Former participation in the DO-HEALTH clinical trial study

Exclusion Criteria:

* Inability or unwillingness to give written informed consent
* 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.

Primary outcomes:
measure: Incidence of functional decline
timeFrame: 24 months
measure: Incidence of injurious falls
timeFrame: 24 months
measure: Incidence of high blood pressure
timeFrame: 24 months
measure: Incidence of cognitive decline
timeFrame: 24 months
measure: Incidence of infections
timeFrame: 24 months
Secondary outcomes:
measure: Incidence and prevalence of frailty
timeFrame: 24 months
measure: Incidence and prevalence of impaired mobility
timeFrame: 24 months
measure: Incidence and prevalence of functional dependency
timeFrame: 24 months
measure: Incidence and prevalence of anemia or iron deficiency
timeFrame: 24 months
measure: Incidence and prevalence of any cardiovascular disease
timeFrame: 24 months
measure: Incidence and prevalence of heart arrhythmia
timeFrame: 24 months
measure: Incidence and prevalence of atrial fibrillation
timeFrame: 24 months
measure: Incidence and prevalence of heart failure, cardiomyopathy, heart valves abnormalities
timeFrame: 24 months
measure: Incidence of stroke
timeFrame: 24 months
measure: Incidence and prevalence of Type 2 diabetes
timeFrame: 24 months
measure: Incidence and prevalence of dementia
timeFrame: 24 months
measure: Incidence and prevalence of osteoarthritis
timeFrame: 24 months
measure: Incidence and prevalence osteoporosis
timeFrame: 24 months
measure: Incidence and prevalence of sarcopenia, osteosarcopenia
timeFrame: 24 months
measure: Incidence and prevalence of any gastrointestinal disease
timeFrame: 24 months
measure: Incidence and prevalence of gastroesophageal reflux disease (GERD)
timeFrame: 24 months
measure: Incidence and prevalence of any micronutrient deficiency (Vitamins, Minerals and fatty acids)
timeFrame: 24 months
measure: Incidence and prevalence of knee buckling
timeFrame: 24 months
measure: Incidence and prevalence of chronic pain
timeFrame: 24 months
measure: Incidence and prevalence of subjective memory complaints
timeFrame: 24 months
measure: Incidence and prevalence of hearing impairment
timeFrame: 24 months
measure: Incidence and prevalence of depression
timeFrame: 24 months
measure: Incidence and prevalence insomnia
timeFrame: 24 months
measure: Incidence and prevalence of chronic inflammation
timeFrame: 24 months
measure: Incidence and prevalence of polypharmacy
timeFrame: 24 months
measure: Incidence and prevalence of inappropriate medication prescription
timeFrame: 24 months
measure: Incidence and prevalence of age related morbidity by individual drug use (e.g. Proton-Pump-Inhibitors, anticoagulants, benzodiazepines, antibiotics)
timeFrame: 24 months
measure: Incidence and prevalence of malnutrition
timeFrame: 24 months
measure: Incidence and prevalence of urinary incontinence
timeFrame: 24 months
measure: Incidence and prevalence of impaired quality of life
timeFrame: 24 months
measure: Incidence and prevalence of functional decline
timeFrame: 24 months
measure: Incidence of fractures
timeFrame: 24 months
measure: Incidence of all-cause hospitalization
timeFrame: 24 months
measure: Incidence and prevalence of frequent health care utilization
timeFrame: 24 months
measure: trajectories of frequent health care utilization
timeFrame: 24 months
measure: Incidence of nursing home placement
timeFrame: 24 months
measure: Incidence of cancer (any cancer, gastro-intestinal, breast cancer in women, prostate cancer in men)
timeFrame: 24 months
measure: Incidence of all-cause mortality
timeFrame: 24 months
measure: Prevalence of MIND diet adherence (DO-HEALTHcohort-MINDful substudy)
timeFrame: 24months
measure: Prevalence and Incidence of Mild Cognitive impairment (DO-HEALTHcohort-MINDful substudy)
timeFrame: 24months
measure: Dual-tasking gait variability (DO-HEALTHcohort-MINDful substudy)
timeFrame: one time
measure: Prevalence of confirmed Covid-19 cases (DO-HEALTHcohort-MINDful substudy)
timeFrame: 24 months
measure: Prevalence of Covid-19 vaccinated participants (DO-HEALTHcohort-MINDful substudy)
timeFrame: 24 months
measure: Prevalence of reported subjective cognitive decline (DO-HEALTHcohort-MINDful substudy)
timeFrame: 24 months
measure: Covid-19 related resilience (DO-HEALTHcohort-MINDful substudy)
timeFrame: one time
measure: Covid-19 related stress (DO-HEALTHcohort-MINDful)
timeFrame: one time
measure: Covid-19 related coping behaviours (DO-HEALTHcohort-MINDful)
timeFrame: one time
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Centre on Aging and Mobility, University of Zurich, City Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Heike Bischoff-Ferrari, Prof. Dr. med. DrPH
role: PRINCIPAL_INVESTIGATOR
References: