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Finnish Vitamin D Trial (FIND) (FIND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01463813
Recruitment Status : Completed
First Posted : November 2, 2011
Last Update Posted : October 23, 2018
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

Tracking Information
First Submitted Date  ICMJE October 13, 2011
First Posted Date  ICMJE November 2, 2011
Last Update Posted Date October 23, 2018
Actual Study Start Date  ICMJE September 2012
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2011)
  • Cardiovascular disease [ Time Frame: 5 years ]
    CVD incidence in VitD arms vs. placebo arm.
  • Cancer [ Time Frame: 5 years ]
    Cancer incidence in VitD arms vs.placebo arm
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Finnish Vitamin D Trial (FIND)
Official Title  ICMJE Finnish Vitamin D Trial (FIND)
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.

Detailed Description More detailed description available upon request.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Diseases
  • Cancer
Intervention  ICMJE
  • Dietary Supplement: Vitamin D3
    Vitamin D3 40 micrograms (1600 IU) per day
    Other Name: Cholecalciferol
  • Dietary Supplement: Vitamin D3
    Vitamin D3 80 micrograms (3200 IU) per day
    Other Name: Cholecalciferol
  • Dietary Supplement: Placebo
    Inactive placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo, no Vitamin D3
    Intervention: Dietary Supplement: Placebo
  • Experimental: Vitamin D3 80
    Vitamin D3 80 micrograms (3200 IU) per day
    Intervention: Dietary Supplement: Vitamin D3
  • Experimental: Vitamin D3 40
    Vitamin D3 40 micrograms (1600 IU) per day
    Intervention: Dietary Supplement: Vitamin D3
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2015)
2495
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2011)
18000
Actual Study Completion Date  ICMJE October 2018
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01463813
Other Study ID Numbers  ICMJE FIND
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tomi-Pekka Tuomainen, University of Eastern Finland
Study Sponsor  ICMJE University of Eastern Finland
Collaborators  ICMJE
  • Academy of Finland
  • Juho Vainio Foundation
  • Finnish Foundation for Cardiovascular Research
  • Finnish Cultural Foundation
Investigators  ICMJE
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
PRS Account University of Eastern Finland
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP