Finnish Vitamin D Trial (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: March 25, 2015
Last verified: March 2015
  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:


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
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

No publications provided

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: March 25, 2015
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
Bone Density Conservation Agents
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 03, 2015