Finnish Vitamin D Trial (FIND) (FIND)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Cancer
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Vitamin D3; Dietary supplement: Vitamin D3

Detailed Description

More detailed description available upon request.

• Study Type: Interventional
• Enrollment (Actual): 2495
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Savo
    • Kuopio, Savo, Finland, 70211
      • University of Eastern Finland, Kuopio campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo, no Vitamin D3	Dietary supplement: Placebo; Inactive placebo
Experimental: Vitamin D3 80; Vitamin D3 80 micrograms (3200 IU) per day	Dietary supplement: Vitamin D3; Vitamin D3 40 micrograms (1600 IU) per day; Other Names: Cholecalciferol; Dietary supplement: Vitamin D3; Vitamin D3 80 micrograms (3200 IU) per day; Other Names: Cholecalciferol
Experimental: Vitamin D3 40; Vitamin D3 40 micrograms (1600 IU) per day	Dietary supplement: Vitamin D3; Vitamin D3 40 micrograms (1600 IU) per day; Other Names: Cholecalciferol; Dietary supplement: Vitamin D3; Vitamin D3 80 micrograms (3200 IU) per day; Other Names: Cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular disease	CVD incidence in VitD arms vs. placebo arm.	5 years
Cancer	Cancer incidence in VitD arms vs.placebo arm	5 years

Collaborators and Investigators

• Sponsor: University of Eastern Finland
• Collaborators: Finnish Cultural Foundation; Academy of Finland; Juho Vainio Foundation; Finnish Foundation for Cardiovascular Research
• Investigators: Principal Investigator: Jyrki K Virtanen, PhD, University of Eastern Finland; Principal Investigator: Sari Voutilainen, PhD, University of Eastern Finland

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2012
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: October 13, 2011
• First Submitted That Met QC Criteria: November 1, 2011
• First Posted (Estimate): November 2, 2011

Study Record Updates

• Last Update Posted (Actual): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: cancer; cardiovascular disease; diabetes mellitus, type 2; vitamin D; primary prevention; dietary supplements; cholecalciferol; bone density conservation agents
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: FIND