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NCT Number: NCT01463813

Finnish Vitamin D Trial (FIND)

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.

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Key information

Conditions

Cardiovascular Diseases Cancer Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Eastern Finland, Kuopio Campus

Kuopio, Northern Savonia, 70211, Finland

About this study

More detailed description available upon request.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D3

Dietary Supplement

Vitamin D3 40 micrograms (1600 IU) per day

Other names: Cholecalciferol

Placebo

Dietary Supplement

Inactive placebo

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Eastern Finland

Other

Collaborators

  • Academy of Finland
  • Finnish Cultural Foundation
  • Finnish Foundation for Cardiovascular Research
  • Juho Vainio Foundation

Registry information

Acronym: FIND

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Nov 2, 2011
Registry last updated
Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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