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Vitamin D supplementation and prevention of cardiovascular disease and cancer in the Finnish Vitamin D Trial: a randomized controlled trial
Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.
Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.
Independent scientist, Kangasala, Finland.
Departmentof Biostatistics, School of Public Health and Health Sciences, University of Massachusetts, Amherst, MA, USA ; Department of Epidemiology and HealthPromotion and Policy, School of Public Health and Health Sciences, University of Massachusetts, Amherst, MA, USA.
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2022 (English)In: American Journal of Clinical Nutrition, ISSN 0002-9165, E-ISSN 1938-3207, Vol. 115, no 5, p. 1300-1310, article id nqab419Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Vitamin D insufficiency is associated with risk of cardiovascular diseases (CVD) and cancer in observational studies, but evidence for benefits with vitamin D supplementation is limited.

OBJECTIVES: To investigate the effects of vitamin D3 supplementation on CVD and cancer incidence.

DESIGN: The study was a 5-year randomized placebo-controlled trial among 2495 male participants ≥ 60 years and post-menopausal female participants ≥ 65 years from a general Finnish population who were free of prior CVD or cancer. The study had three arms: placebo, 1600 IU/day or 3200 IU/day vitamin D3. Follow-up was by annual study questionnaires and national registry data. A representative sub-cohort of 551 participants had more detailed in-person investigations. The primary endpoints were incident major CVD and invasive cancer. Secondary endpoints included the individual components of the primary CVD endpoint (myocardial infarction, stroke, and CVD mortality), site-specific cancers and cancer death.

RESULTS: During the follow-up, there were 41 (4.9%), 42 (5.0%) and 36 (4.3%) major CVD events in the placebo, 1600 IU/d (vs. placebo: hazard ratio (HR), 0.97;95% CI, 0.63,1.49; P = 0.89), and 3200 IU/d (HR, 0.84;95% CI, 0.54,1.31; P = 0.44) arms, respectively. Invasive cancer was diagnosed in 41 (4.9%), 48 (5.8%) and 40 (4.8%) participants in the placebo, 1600 IU/d (HR, 1.14;95% CI, 0.75,1.72; P = 0.55), and 3200 IU/d (HR, 0.95;95% CI, 0.61,1.47; P = 0.81) arms, respectively. There were no significant differences in the secondary endpoints or total mortality. In the sub-cohort, the mean (standard deviation) baseline serum 25-hydroxyvitamin D concentration was 75 (18) nmol/L. After 12 months, the concentrations were 73 (18) nmol/L, 100 (21) nmol/L and 120 (22) nmol/L in the placebo, 1600 IU/d and 3200 IU/d arms, respectively.

CONCLUSIONS: Vitamin D3 supplementation did not lower the incidence of major CVD events or invasive cancer among older adults, possibly due to sufficient vitamin D status in most participants at baseline. Clinical Trial Registry number: ClinicalTrials.gov: NCT01463813, https://clinicaltrials.gov/ct2/show/NCT01463813.

Place, publisher, year, edition, pages
Oxford University Press, 2022. Vol. 115, no 5, p. 1300-1310, article id nqab419
Keywords [en]
cancer, cardiovascular disease, elderly, randomized controlled trial, supplementation study, vitamin d
National Category
Public Health, Global Health, Social Medicine and Epidemiology
Research subject
Research on Citizen Centered Health, University of Skövde (Reacch US)
Identifiers
URN: urn:nbn:se:his:diva-20989DOI: 10.1093/ajcn/nqab419ISI: 000764794200001PubMedID: 34982819Scopus ID: 2-s2.0-85127765971OAI: oai:DiVA.org:his-20989DiVA, id: diva2:1645531
Funder
Academy of Finland, #137826
Note

CC BY 4.0

Virtanen, Jyrki K.(corresponding author)

Published: 04 January 2022

This study was supported by funding from the Academy of Finland (#137826), University of Eastern Finland, Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and Finnish Cultural Foundation.

Available from: 2022-03-18 Created: 2022-03-18 Last updated: 2022-09-02Bibliographically approved

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