Finnish Vitamin D Trial (FIND) (FIND)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Academy of Finland

Juho Vainio Foundation

Finnish Foundation for Cardiovascular Research

Finnish Cultural Foundation

Information provided by (Responsible Party):

Tomi-Pekka Tuomainen, University of Eastern Finland

ClinicalTrials.gov Identifier:

NCT01463813

First received: October 13, 2011

Last updated: May 13, 2016

Last verified: May 2016

History of Changes

Purpose

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	Intervention
Cardiovascular Diseases Cancer	Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Finnish Vitamin D Trial (FIND)

Resource links provided by NLM:

MedlinePlus related topics: Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Further study details as provided by University of Eastern Finland:

Primary Outcome Measures:

Cardiovascular disease [ Time Frame: 5 years ] [ Designated as safety issue: No ]
CVD incidence in VitD arms vs. placebo arm.
Cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Cancer incidence in VitD arms vs.placebo arm


Enrollment:	2495
Study Start Date:	September 2012
Estimated Study Completion Date:	December 2018
Estimated Primary Completion Date:	June 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Detailed Description:

More detailed description available upon request.

Eligibility


Ages Eligible for Study:	60 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463813

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


Responsible Party:	Tomi-Pekka Tuomainen, Professor, University of Eastern Finland
ClinicalTrials.gov Identifier:	NCT01463813 History of Changes
Other Study ID Numbers:	FIND
Study First Received:	October 13, 2011
Last Updated:	May 13, 2016
Health Authority:	Finland: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on September 23, 2016

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