Finnish Vitamin D Trial (FIND) (FIND)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Diseases; Cancer	Dietary Supplement: Vitamin D3; Dietary Supplement: Placebo	Not Applicable

Detailed Description:

More detailed description available upon request.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2495 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Finnish Vitamin D Trial (FIND)
Study Start Date :	September 2012
Estimated Primary Completion Date :	June 2018
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 80 micrograms (3200 IU) per day; Other Name: 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 Name: Cholecalciferol

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Cardiovascular disease [ Time Frame: 5 years ]
   CVD incidence in VitD arms vs. placebo arm.
2. Cancer [ Time Frame: 5 years ]
   Cancer incidence in VitD arms vs.placebo arm

Eligibility Criteria

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Ages Eligible for Study:	60 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Finland
University of Eastern Finland, Kuopio Campus
Kuopio, Savo, Finland, 70211

Sponsors and Collaborators

University of Eastern Finland

Academy of Finland

Juho Vainio Foundation

Finnish Foundation for Cardiovascular Research

Finnish Cultural Foundation

Investigators

Principal Investigator:	Tomi-Pekka Tuomainen, MD, PhD	University of Eastern Finland
Principal Investigator:	Jyrki K Virtanen, PhD	University of Eastern Finland
Principal Investigator:	Sari Voutilainen, PhD	University of Eastern Finland

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Tomi-Pekka Tuomainen, Professor, University of Eastern Finland
ClinicalTrials.gov Identifier:	NCT01463813 History of Changes
Other Study ID Numbers:	FIND
First Posted:	November 2, 2011
Last Update Posted:	November 8, 2017
Last Verified:	November 2017

Keywords provided by Tomi-Pekka Tuomainen, University of Eastern Finland:

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

Additional relevant MeSH terms:

Cardiovascular Diseases; Vitamins; Vitamin D; Ergocalciferols; Cholecalciferol	Bone Density Conservation Agents; Micronutrients; Growth Substances; Physiological Effects of Drugs