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Finnish Vitamin D Trial (FIND) (FIND)

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ClinicalTrials.gov Identifier: NCT01463813
Recruitment Status : Active, not recruiting
First Posted : November 2, 2011
Last Update Posted : November 8, 2017
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

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

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



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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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    Key Record Dates
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