Finnish Vitamin D Trial (FIND)

Cancer Clinical Trial

— FIND  

Official title:

Finnish Vitamin D Trial (FIND)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463813
• Other study ID #: FIND
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: October 2018

Study information

• Verified date: October 2018
• Source: University of Eastern Finland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

More detailed description available upon request.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2495
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Vitamin D3
Vitamin D3 40 micrograms (1600 IU) per day
• Vitamin D3
Vitamin D3 80 micrograms (3200 IU) per day
• Placebo
Inactive placebo

Locations

Country	Name	City	State
Finland	University of Eastern Finland, Kuopio Campus	Kuopio	Savo

Sponsors (5)

Lead Sponsor	Collaborator
University of Eastern Finland	Academy of Finland, Finnish Cultural Foundation, Finnish Foundation for Cardiovascular Research, Juho Vainio Foundation

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular disease	CVD incidence in VitD arms vs. placebo arm.	5 years
Primary	Cancer	Cancer incidence in VitD arms vs.placebo arm	5 years