Effects of Supplemental Vitamin D on Bone Health Outcomes in Women and Men in the VITamin D and OmegA-3 TriaL (VITAL).

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  • Additional Information
    • Source:
      Publisher: American Society for Bone and Mineral Research Country of Publication: United States NLM ID: 8610640 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1523-4681 (Electronic) Linking ISSN: 08840431 NLM ISO Abbreviation: J Bone Miner Res Subsets: MEDLINE
    • Publication Information:
      Publication: 2000- : Washington, DC : American Society for Bone and Mineral Research
      Original Publication: New York : Mary Ann Liebert, Inc., c1986-
    • Subject Terms:
      Fatty Acids, Omega-3* ; Vitamin D*; Absorptiometry, Photon ; Adult ; Bone Density ; Dietary Supplements ; Female ; Femur Neck/diagnostic imaging ; Fibroblast Growth Factor-23 ; Humans ; Male ; Netherlands ; Outcome Assessment, Health Care
    • Abstract:
      Although supplemental vitamin D is used to promote bone health in the general population, data from randomized controlled trials (RCTs) have been inconsistent. We determined whether daily, vitamin D 3 supplementation improves bone mineral density (BMD) and/or structure. VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, placebo-controlled RCT of supplemental vitamin D 3 (2000 IU/d) and/or omega-3 fatty acids (1 g/d) in 25,871 adults nationwide. This ancillary study included a subcohort of 771 participants (men ≥50 and women ≥55 years; not taking bone active medications) evaluated at baseline and at 2-year follow-up (89% retention). Total 25(OH)D levels were measured by liquid chromatography tandem mass spectrometry (Quest Diagnostics, San Juan Capistrano, CA, USA). Free 25(OH)D (FVD) levels were measured using the ELISA assay by Future Diagnostics Solutions BV (Wijchen, Netherlands). Primary endpoints were 2-year changes in areal (a) BMD at the spine, hip, and whole body determined by dual-energy X-ray absorptiometry (DXA). Secondary endpoints were 2-year changes in volumetric (v) BMD and cortical thickness at the radius and tibia assessed by peripheral quantitative computed tomography. Supplemental vitamin D 3 versus placebo had no effect on 2-year changes in aBMD at the spine (0.33% versus 0.17%; p = 0.55), femoral neck (-0.27% versus -0.68%; p = 0.16), total hip (-0.76% versus -0.95%; p = 0.23), or whole body (-0.22% versus -0.15%; p = 0.60), or on measures of bone structure. Effects did not vary by sex, race/ethnicity, body mass index, or 25(OH)D levels. Among participants with baseline FVD levels below the median (<14.2 pmol/L), there was a slight increase in spine aBMD (0.75% versus 0%; p = 0.043) and attenuation in loss of total hip aBMD (-0.42% versus -0.98%; p = 0.044) with vitamin D 3 . Whether baseline FVD levels help to identify those more likely to benefit from supplementation warrants further study. Supplemental vitamin D 3 versus placebo for 2 years in general healthy adults not selected for vitamin D insufficiency did not improve BMD or structure. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.
      (© 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.)
    • References:
      Osteoporos Int. 2014 Oct;25(10):2359-81. (PMID: 25182228)
      Calcif Tissue Int. 2013 Jul;93(1):69-77. (PMID: 23591713)
      N Engl J Med. 1988 Dec 29;319(26):1701-7. (PMID: 3205267)
      Ann Intern Med. 2011 Dec 20;155(12):827-38. (PMID: 22184690)
      Calcif Tissue Int. 2019 Feb;104(2):160-170. (PMID: 30293198)
      Am J Clin Nutr. 2000 Sep;72(3):690-3. (PMID: 10966885)
      J Clin Endocrinol Metab. 2013 Dec;98(12):4619-28. (PMID: 24106283)
      Evid Rep Technol Assess (Full Rep). 2009 Aug;(183):1-420. (PMID: 20629479)
      Contemp Clin Trials. 2018 Apr;67:56-67. (PMID: 29408561)
      Am J Clin Nutr. 2019 Jul 1;110(1):150-157. (PMID: 31076739)
      Osteoporos Int. 1997;7(5):439-43. (PMID: 9425501)
      J Intern Med. 2018 Dec;284(6):685-693. (PMID: 30137647)
      J Bone Miner Res. 2011 Jul;26(7):1609-16. (PMID: 21416506)
      N Engl J Med. 1997 Sep 4;337(10):670-6. (PMID: 9278463)
      J Bone Miner Res. 2015 Mar;30(3):562-9. (PMID: 25418140)
      Contemp Clin Trials. 2016 Mar;47:235-43. (PMID: 26767629)
      Am J Clin Nutr. 2004 Dec;80(6 Suppl):1689S-96S. (PMID: 15585789)
      J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. (PMID: 21646368)
      J Steroid Biochem Mol Biol. 2017 Oct;173:105-116. (PMID: 28093353)
      Age Ageing. 2004 Jan;33(1):45-51. (PMID: 14695863)
      JAMA. 2019 Aug 27;322(8):736-745. (PMID: 31454046)
      Bone. 2004 Jul;35(1):320-5. (PMID: 15207773)
      Cochrane Database Syst Rev. 2014 Apr 14;(4):CD000227. (PMID: 24729336)
      J Clin Endocrinol Metab. 2014 May;99(5):1631-7. (PMID: 24483159)
      Lancet Diabetes Endocrinol. 2018 Nov;6(11):847-858. (PMID: 30293909)
      Osteoporos Int. 2012 Oct;23(10):2461-7. (PMID: 22215183)
      Ann Intern Med. 1996 Feb 15;124(4):400-6. (PMID: 8554248)
      JAMA Intern Med. 2015 Oct;175(10):1612-21. (PMID: 26237520)
      Osteoporos Int. 2010 Jul;21(7):1151-4. (PMID: 20422154)
      Am J Clin Nutr. 2018 Sep 1;108(3):633-640. (PMID: 30007343)
      Am J Med. 2004 May 1;116(9):634-9. (PMID: 15093761)
      Osteoporos Int. 2017 Sep;28(9):2619-2631. (PMID: 28660495)
      Osteoporos Int. 2016 Feb;27(2):617-26. (PMID: 26359185)
      N Engl J Med. 2006 Feb 16;354(7):669-83. (PMID: 16481635)
      J Clin Endocrinol Metab. 1995 Apr;80(4):1052-8. (PMID: 7714065)
      Contemp Clin Trials. 2015 Mar;41:259-68. (PMID: 25623291)
      Saudi Med J. 2004 Mar;25(3):355-8. (PMID: 15048176)
      Am J Clin Nutr. 2016 Jul;104(1):205-14. (PMID: 27194308)
      J Bone Miner Res. 2018 Aug;33(8):1464-1469. (PMID: 29665087)
      Evid Rep Technol Assess (Full Rep). 2007 Aug;(158):1-235. (PMID: 18088161)
      N Engl J Med. 1992 Dec 3;327(23):1637-42. (PMID: 1331788)
      J Bone Miner Res. 2011 May;26(5):1145-53. (PMID: 21542014)
      J Steroid Biochem Mol Biol. 2014 Oct;144 Pt A:132-7. (PMID: 24095930)
      Calcif Tissue Int. 2013 Feb;92(2):99-105. (PMID: 22903507)
      J Intern Med. 2017 Nov;282(5):452-460. (PMID: 28692172)
      J Clin Densitom. 2011 Apr-Jun;14(2):79-84. (PMID: 21787514)
      Clin Endocrinol (Oxf). 2010 Nov;73(5):573-80. (PMID: 20718769)
      J Clin Densitom. 2011 Jul-Sep;14(3):367-73. (PMID: 21723765)
      J Bone Miner Res. 2013 Oct;28(10):2202-13. (PMID: 23585346)
      Evid Rep Technol Assess (Full Rep). 2014 Sep;(217):1-929. (PMID: 30313003)
      Lancet. 2014 Jan 11;383(9912):146-55. (PMID: 24119980)
      N Engl J Med. 2011 Jan 20;364(3):248-54. (PMID: 21247315)
      JAMA. 2016 Oct 11;316(14):1464-1474. (PMID: 27727382)
      N Engl J Med. 2019 Jan 3;380(1):33-44. (PMID: 30415629)
    • Grant Information:
      United States AT NCCIH NIH HHS; R01 CA138962 United States CA NCI NIH HHS; UL1TR001102 United States RR NCRR NIH HHS; R01 AR059775 United States AR NIAMS NIH HHS; U01 CA138962 United States CA NCI NIH HHS; United States NS NINDS NIH HHS; R01 DK112940 United States DK NIDDK NIH HHS; R01 AR060574 United States AR NIAMS NIH HHS; R01 HL134811 United States HL NHLBI NIH HHS; United States CC CDC HHS; K24 HL136852 United States HL NHLBI NIH HHS; R01 AR070854 United States AR NIAMS NIH HHS; UL1 TR001102 United States TR NCATS NIH HHS
    • Contributed Indexing:
      Keywords: BONE QCT; DXA; GENERAL POPULATION STUDIES; OSTEOPOROSIS; PTH/VITD/FGF23
    • Molecular Sequence:
      ClinicalTrials.gov NCT01747447; NCT01169259
    • Accession Number:
      0 (FGF23 protein, human)
      0 (Fatty Acids, Omega-3)
      1406-16-2 (Vitamin D)
      7Q7P4S7RRE (Fibroblast Growth Factor-23)
    • Publication Date:
      Date Created: 20200111 Date Completed: 20210728 Latest Revision: 20220731
    • Publication Date:
      20240829
    • Accession Number:
      PMC7217747
    • Accession Number:
      10.1002/jbmr.3958
    • Accession Number:
      31923341