Finnish Vitamin D Trial (FIND)

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Cancer
• Interventions: Dietary Supplement: Vitamin D3; Dietary Supplement: Placebo

• Registration Number: NCT01463813
• Lead Sponsor: University of Eastern Finland

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.

Study Timeline

• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-11-01
• Study First Posted: 2011-11-02
• Study Start: 2012-09
• Status Verified: 2018-10
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2495

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D3 80	Vitamin D3	Vitamin D3 80 micrograms (3200 IU) per day
Vitamin D3 40	Vitamin D3	Vitamin D3 40 micrograms (1600 IU) per day
Placebo	Placebo	Placebo, no Vitamin D3

Primary Outcome Measures

Name	Time	Method
Cardiovascular disease	5 years	CVD incidence in VitD arms vs. placebo arm.
Cancer	5 years	Cancer incidence in VitD arms vs.placebo arm

Trial Locations

Locations (1)

University of Eastern Finland, Kuopio Campus; 🇫🇮 Kuopio, Savo, Finland