NCT01463813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,495

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 2, 2011

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

6.1 years

First QC Date

October 13, 2011

Last Update Submit

October 22, 2018

Conditions

Cardiovascular DiseasesCancer

Keywords

bone density conservation agentscancercardiovascular diseasecholecalciferoldiabetes mellitus, type 2dietary supplementsprimary preventionvitamin D

Outcome Measures

Primary Outcomes (2)

  • Cardiovascular disease

    CVD incidence in VitD arms vs. placebo arm.

    5 years

  • Cancer

    Cancer incidence in VitD arms vs.placebo arm

    5 years

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo, no Vitamin D3

Dietary Supplement: Placebo

Vitamin D3 80

EXPERIMENTAL

Vitamin D3 80 micrograms (3200 IU) per day

Dietary Supplement: Vitamin D3

Vitamin D3 40

EXPERIMENTAL

Vitamin D3 40 micrograms (1600 IU) per day

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3DIETARY_SUPPLEMENT

Vitamin D3 40 micrograms (1600 IU) per day

Also known as: Cholecalciferol
Vitamin D3 40
PlaceboDIETARY_SUPPLEMENT

Inactive placebo

Placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men 60 years or older
  • Women 65 years or older

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Eastern Finland, Kuopio Campus

Kuopio, Northern Savonia, 70211, Finland

Location

Related Publications (5)

  • Rikkonen T, Hantunen S, Kroger H, Lamberg-Allardt C, Manson JE, Nurmi T, Tuppurainen M, Voutilainen A, Tuomainen TP, Virtanen JK. The Effect of Vitamin D3 Supplementation on the Risk of Falls in a General Population-The Finnish Vitamin D Trial. J Am Geriatr Soc. 2026 Jan 13. doi: 10.1111/jgs.70295. Online ahead of print.

    PMID: 41531181DERIVED

  • Ahl NM, Hantunen S, Tuomainen TP, Lamberg-Allardt C, Manson JE, Nurmi T, Uusitupa M, Voutilainen A, Tolmunen T, Virtanen JK. Vitamin D supplementation and incidence of major depressive disorder - A randomized clinical trial. Clin Nutr. 2025 Dec 30;57:106570. doi: 10.1016/j.clnu.2025.106570. Online ahead of print.

    PMID: 41506003DERIVED

  • 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.

    PMID: 40243375DERIVED

  • 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.

    PMID: 39621103DERIVED

  • 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.

    PMID: 37302737DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesNeoplasmsDiabetes Mellitus, Type 2

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 13, 2011

First Posted

November 2, 2011

Study Start

September 1, 2012

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

October 23, 2018

Record last verified: 2018-10

Locations

FI(1)