Finnish Vitamin D Trial (FIND)

NCT ID: NCT01463813

Last Updated: 2018-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2495 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2018-10-31

Brief Summary

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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.

Detailed Description

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More detailed description available upon request.

Conditions

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Cardiovascular Diseases Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo, no Vitamin D3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Inactive placebo

Vitamin D3 80

Vitamin D3 80 micrograms (3200 IU) per day

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 80 micrograms (3200 IU) per day

Vitamin D3 40

Vitamin D3 40 micrograms (1600 IU) per day

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 40 micrograms (1600 IU) per day

Interventions

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Vitamin D3

Vitamin D3 40 micrograms (1600 IU) per day

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3 80 micrograms (3200 IU) per day

Intervention Type DIETARY_SUPPLEMENT

Placebo

Inactive placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Cholecalciferol Cholecalciferol

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Academy of Finland

OTHER

Sponsor Role collaborator

Juho Vainio Foundation

OTHER

Sponsor Role collaborator

Finnish Foundation for Cardiovascular Research

OTHER

Sponsor Role collaborator

Finnish Cultural Foundation

OTHER

Sponsor Role collaborator

University of Eastern Finland

OTHER

Sponsor Role lead

Responsible Party

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Tomi-Pekka Tuomainen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tomi-Pekka Tuomainen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Finland

Jyrki K Virtanen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Finland

Sari Voutilainen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Finland

Locations

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University of Eastern Finland, Kuopio Campus

Kuopio, Northern Savonia, Finland

Site Status

Countries

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Finland

References

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Lonnroos E, Ylilauri M, Lamberg-Allardt C, Manson JE, Nurmi T, Uusitupa M, Voutilainen A, Hantunen S, Tuomainen TP, Virtanen JK. The Effect of Vitamin D3 Supplementation on the Incidence of Diagnosed Dementia Among Healthy Older Adults-The Finnish Vitamin D Trial. J Gerontol A Biol Sci Med Sci. 2025 Jun 10;80(7):glaf077. doi: 10.1093/gerona/glaf077.

Reference Type DERIVED
PMID: 40243375 (View on PubMed)

Virtanen JK, Hantunen S, Kallio N, Lamberg-Allardt C, Manson JE, Nurmi T, Pihlajamaki J, Uusitupa M, Voutilainen A, Tuomainen TP. The effect of vitamin D3 supplementation on the incidence of type 2 diabetes in healthy older adults not at high risk for diabetes (FIND): a randomised controlled trial. Diabetologia. 2025 Apr;68(4):715-726. doi: 10.1007/s00125-024-06336-9. Epub 2024 Dec 2.

Reference Type DERIVED
PMID: 39621103 (View on PubMed)

Virtanen JK, Hantunen S, Lamberg-Allardt C, Manson JE, Nurmi T, Uusitupa M, Voutilainen A, Tuomainen TP. The effect of vitamin D3 supplementation on atrial fibrillation in generally healthy men and women: The Finnish Vitamin D Trial. Am Heart J. 2023 Oct;264:177-182. doi: 10.1016/j.ahj.2023.05.024. Epub 2023 Jun 10.

Reference Type DERIVED
PMID: 37302737 (View on PubMed)

Other Identifiers

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FIND

Identifier Type: -

Identifier Source: org_study_id

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