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Finnish Vitamin D Trial (FIND)

This study is not yet open for participant recruitment.
Verified October 2011 by University of Eastern Finland
Sponsor:
Collaborators:
Academy of Finland
Juho Vainio Foundation
Finnish Foundation for Cardiovascular Research
Information provided by (Responsible Party):
Tomi-Pekka Tuomainen, University of Eastern Finland
ClinicalTrials.gov Identifier:
NCT01463813
First received: October 13, 2011
Last updated: November 1, 2011
Last verified: October 2011
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.

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.

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, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Finnish Vitamin D Trial (FIND)

Resource links provided by NLM:

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


Estimated Enrollment: 18000
Study Start Date: January 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Dietary Supplement: Placebo
Inactive placebo
Experimental: Vitamin D 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

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

Contacts
Contact: Tomi-Pekka Tuomainen, MD, PhD 358 40 355 2956 tomi-pekka.tuomainen@uef.fi
Contact: Jyrki Virtanen, PhD 358 40 355 2957 jyrki.virtanen@uef.fi

Locations
Finland
University of Eastern Finland, Kuopio Campus Not yet recruiting
Kuopio, Finland, 70211
Contact: Tomi-Pekka Tuomainen, MD, PhD     358 40 355 2956     tomi-pekka.tuomainen@uef.fi    
Principal Investigator: Tomi-Pekka Tuomainen, MD, PhD            
Principal Investigator: Jyrki K Virtanen, PhD            
Principal Investigator: Sari Voutilainen, PhD            
Sub-Investigator: Tarja Nurmi, PhD            
Sub-Investigator: Jaakko Mursu, PhD            
Sub-Investigator: Heikki Kröger, MD, PhD            
Sub-Investigator: Matti Uusitupa, MD, PhD            
Sub-Investigator: Marjo Tuppurainen, MD, PhD            
Sub-Investigator: Christel Lamberg-Allardt, PhD            
Sub-Investigator: Antti Aro, MD, PhD            
Sub-Investigator: JoAnn Manson, MD, PhD            
Sponsors and Collaborators
University of Eastern Finland
Academy of Finland
Juho Vainio Foundation
Finnish Foundation for Cardiovascular Research
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: November 1, 2011
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
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
 Bone Density Conservation Agents
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013