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Finnish Vitamin D Trial (FIND)

Finnish Vitamin D Trial (FIND)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01463813
Acronym
FIND
Enrollment
2495
Registered
2011-11-02
Start date
2012-09-30
Completion date
2018-10-31
Last updated
2018-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Cardiovascular Diseases

Keywords

bone density conservation agents, cancer, cardiovascular disease, cholecalciferol, diabetes mellitus, type 2, dietary supplements, primary prevention, vitamin D

Brief summary

The Finnish Vitamin D Trial (FIND) is a randomized, double-blind, placebo-controlled, 5-year supplementation study of the benefits and risks of vitamin D in the primary prevention of cardiovascular (CVD) and cancer among 18000 men 60 years or older and women 65 years or older. \[Edit 25.3.2015: Due to difficulties in recruitment and funding, the study size is approximately 2500 subjects, with a 550 subject subgroup with more detailed examinations\] The participants will be randomized to 3 groups with 6000 in each, with daily supplementation of either: 1) 40 µg/day (1600 IU) of vitamin D3, 2) 80 µg/day (3200 IU) of vitamin D3, or 3) placebo. \[Edit 15.3.2015: The 2500 subjects are randomized in 3 groups, approximately 830 subjects per group.\] Compliance, use of non-study drugs or supplements, diet, development of endpoints, and CVD and cancer risk factors will be assessed by questionnaires. Blood samples will be collected for assessment of effect modification by baseline 25-hydroxyvitamin D, as well as for future ancillary studies of genetic/biochemical hypotheses. Event data will be obtained by record linkage from the national computerized hospitalization registry.

Detailed description

More detailed description available upon request.

Interventions

DIETARY_SUPPLEMENTVitamin D3

Vitamin D3 40 micrograms (1600 IU) per day

DIETARY_SUPPLEMENTPlacebo

Inactive placebo

Sponsors

Academy of Finland
CollaboratorOTHER
Juho Vainio Foundation
CollaboratorOTHER
Finnish Foundation for Cardiovascular Research
CollaboratorOTHER
Finnish Cultural Foundation
CollaboratorOTHER
University of Eastern Finland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Men 60 years or older * Women 65 years or older

Exclusion criteria

* Cardiovascular disease (including myocardial infarction, stroke, transient ischemic attack, angina pectoris, coronary artery bypass grafting, or percutaneous coronary intervention). * Cancer (except non-melanoma skin cancer). * Any disease or state that raises a vitamin D related safety concern (such as chronic liver, thyroid or kidney disease, hypercalcemia, sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or Wegener's granulomatosis). * Use of supplements yielding vitamin D over 20 µg/day or calcium over 1200 mg/day and unwillingness to discontinue the use.

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular disease5 yearsCVD incidence in VitD arms vs. placebo arm.
Cancer5 yearsCancer incidence in VitD arms vs.placebo arm

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026