Finnish Vitamin D Trial (FIND)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified December 2013 by University of Eastern Finland
Sponsor:
University of Eastern Finland
Collaborators:
Academy of Finland
Juho Vainio Foundation
Finnish Foundation for Cardiovascular Research
Information provided by (Responsible Party):
Tomi-Pekka Tuomainen, University of Eastern Finland
ClinicalTrials.gov Identifier:
NCT01463813
First received: October 13, 2011
Last updated: December 20, 2013
Last verified: December 2013
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Purpose
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.
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.
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 | Intervention |
|---|---|
|
Cardiovascular Diseases Cancer |
Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Finnish Vitamin D Trial (FIND) |
Resource links provided by NLM:
Further study details as provided by University of Eastern Finland:
Primary Outcome Measures:
- Cardiovascular disease [ Time Frame: 5 years ] [ Designated as safety issue: No ]CVD incidence in VitD arms vs. placebo arm.
- Cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ]Cancer incidence in VitD arms vs.placebo arm
| Estimated Enrollment: | 18000 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2019 |
| Estimated Primary Completion Date: | December 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Placebo, no Vitamin D3
|
Dietary Supplement: Placebo
Inactive placebo
|
|
Experimental: Vitamin D3 80
Vitamin D3 80 micrograms (3200 IU) per day
|
Dietary Supplement: Vitamin D3
Vitamin D3 80 micrograms (3200 IU) per day
Other Name: Cholecalciferol
|
|
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
|
Detailed Description:
More detailed description available upon request.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463813
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463813
Contacts
| Contact: Tomi-Pekka Tuomainen, MD, PhD | 358 40 355 2956 | tomi-pekka.tuomainen@uef.fi | |
| Contact: Jyrki Virtanen, PhD | 358 40 355 2957 | jyrki.virtanen@uef.fi |
Locations
| Finland | |
| University of Eastern Finland, Kuopio Campus | Recruiting |
| Kuopio, Savo, Finland, 70211 | |
| Contact: Tomi-Pekka Tuomainen, MD, PhD 358 40 355 2956 tomi-pekka.tuomainen@uef.fi | |
| Principal Investigator: Tomi-Pekka Tuomainen, MD, PhD | |
| Principal Investigator: Jyrki K Virtanen, PhD | |
| Principal Investigator: Sari Voutilainen, PhD | |
| Sub-Investigator: Tarja Nurmi, PhD | |
| Sub-Investigator: Jaakko Mursu, PhD | |
| Sub-Investigator: Heikki Kröger, MD, PhD | |
| Sub-Investigator: Matti Uusitupa, MD, PhD | |
| Sub-Investigator: Marjo Tuppurainen, MD, PhD | |
| Sub-Investigator: Christel Lamberg-Allardt, PhD | |
| Sub-Investigator: Antti Aro, MD, PhD | |
| Sub-Investigator: JoAnn Manson, MD, PhD | |
Sponsors and Collaborators
University of Eastern Finland
Academy of Finland
Juho Vainio Foundation
Finnish Foundation for Cardiovascular Research
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Tomi-Pekka Tuomainen, Professor, University of Eastern Finland |
| ClinicalTrials.gov Identifier: | NCT01463813 History of Changes |
| Other Study ID Numbers: | FIND |
| Study First Received: | October 13, 2011 |
| Last Updated: | December 20, 2013 |
| Health Authority: | Finland: Ethics Committee |
Keywords provided by 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 Cholecalciferol Ergocalciferols Vitamin D Vitamins |
Bone Density Conservation Agents Growth Substances Micronutrients Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 27, 2015