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
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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 |
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 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo, no Vitamin D3
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Dietary Supplement: Placebo
Inactive placebo
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Experimental: Vitamin D3 80
Vitamin D3 80 micrograms (3200 IU) per day
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Dietary Supplement: Vitamin D3
Vitamin D3 80 micrograms (3200 IU) per day
Other Name: Cholecalciferol
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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
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- 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

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Ages Eligible for Study: | 60 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
Finland | |
University of Eastern Finland, Kuopio Campus | |
Kuopio, Savo, Finland, 70211 |
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 |