Finnish Vitamin D Trial (FIND)

NCT01463813 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2495

Last updated 2018-10-23

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3 40 micrograms (1600 IU) per day

DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3 80 micrograms (3200 IU) per day

DIETARY_SUPPLEMENT

Placebo

Inactive placebo

Sponsors & Collaborators

  • Academy of Finland

    collaborator OTHER
  • Juho Vainio Foundation

    collaborator OTHER
  • Finnish Foundation for Cardiovascular Research

    collaborator OTHER
  • Finnish Cultural Foundation

    collaborator OTHER
  • University of Eastern Finland

    lead OTHER

Principal Investigators

  • Tomi-Pekka Tuomainen, MD, PhD · University of Eastern Finland

  • Jyrki K Virtanen, PhD · University of Eastern Finland

  • Sari Voutilainen, PhD · University of Eastern Finland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01463813 on ClinicalTrials.gov