The Vitamin D Assessment (ViDA) Study: design of a randomized controlled trial of vitamin D supplementation for the prevention of cardiovascular disease, acute respiratory infection, falls and non-vertebral fractures

Journal of Steroid Biochemistry and Molecular Biology

Volumn 164, Issue , 2016, Pages 318-325

  Scragg, Robert ^a   Waayer, Debbie ^a   Stewart, Alistair W ^a   Lawes, Carlene M M ^a   Toop, Les ^b   Murphy, Judy ^a   Khaw, Kay Tee ^c   Camargo, Carlos A ^d  

^a UNIVERSITY OF AUCKLAND   (New Zealand)

^b UNIVERSITY OF OTAGO   (New Zealand)

^c UNIVERSITY OF CAMBRIDGE   (United Kingdom)

^d HARVARD MEDICAL SCHOOL   (United States)

Author keywords

Acute respiratory infection; Cardiovascular disease; Falls; Fractures; Prevention; Randomized controlled trial; Supplement; Vitamin D

Indexed keywords

COLECALCIFEROL; VITAMIN D;

ADULT; AGED; BLOOD PRESSURE; BLOOD SAMPLING; BONE DENSITY; CANCER REGISTRY; CARDIOVASCULAR DISEASE; CHRONIC PAIN; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG SAFETY; FALLING; FEMALE; FRACTURE; GAIT; HEART RATE VARIABILITY; HOSPITALIZATION; HUMAN; LIFESTYLE; LUNG FUNCTION; MAJOR CLINICAL STUDY; MALE; MAORI (PEOPLE); MEDICAL HISTORY; MEDICATION COMPLIANCE; MORTALITY; MUSCLE FUNCTION; MUSCLE STRENGTH; NEW ZEALAND; PACIFIC ISLANDER; PATIENT COMPLIANCE; PRESCRIPTION; PSORIASIS; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; REVIEW; SOUTH ASIAN; STUDY DESIGN; VITAMIN D DEFICIENCY; VITAMIN SUPPLEMENTATION; AFFECT; BODY EQUILIBRIUM; CARDIOVASCULAR DISEASES; DIETARY SUPPLEMENT; DRUG EFFECTS; FRACTURES, BONE; HEART RATE; LUNG FUNCTION TEST; METABOLISM; METHODOLOGY; MIDDLE AGED; PATHOLOGY; PHYSIOLOGY; PREVENTION AND CONTROL; QUESTIONNAIRE; RESPIRATORY TRACT INFECTIONS; VERY ELDERLY;

ACCIDENTAL FALLS; AFFECT; AGED; AGED, 80 AND OVER; BLOOD PRESSURE; CARDIOVASCULAR DISEASES; CHOLECALCIFEROL; DIETARY SUPPLEMENTS; DOUBLE-BLIND METHOD; FEMALE; FRACTURES, BONE; GAIT; HEART RATE; HUMANS; MALE; MIDDLE AGED; MUSCLE STRENGTH; PATIENT COMPLIANCE; POSTURAL BALANCE; RESEARCH DESIGN; RESPIRATORY FUNCTION TESTS; RESPIRATORY TRACT INFECTIONS; SURVEYS AND QUESTIONNAIRES;

EID: 84942064090     PISSN: 09600760     EISSN: 18791220     Source Type: Journal    
DOI: 10.1016/j.jsbmb.2015.09.010     Document Type: Review

References (74)

1. [1] Lee, J.H., O'Keefe, J.H., Bell, D., Hensrud, D.D., Holick, M.F., Vitamin D deficiency an important, common, and easily treatable cardiovascular risk factor?. J. Am. Coll. Cardiol. 52 (2008), 1949–1956.
2. [2] Wallis, D.E., Penckofer, S., Sizemore, G.W., The sunshine deficit and cardiovascular disease. Circulation 118 (2008), 1476–1485.
3. [3] Ginde, A.A., Mansbach, J.M., Camargo, C.A. Jr., Vitamin D, respiratory infections, and asthma. Curr. Allergy Asthma Rep. 9 (2009), 81–87.
4. [4] Ginde, A.A., Mansbach, J.M., Camargo, C.A. Jr., Association between serum 25-hydroxyvitamin D level and upper respiratory tract infection in the Third National Health and Nutrition Examination Survey. Arch. Intern. Med. 169 (2009), 384–390.
5. [5] Snijder, M.B., van Schoor, N.M., Pluijm, S.M., van Dam, R.M., Visser, M., Lips, P., Vitamin D status in relation to one-year risk of recurrent falling in older men and women. J. Clin. Endocrinol. Metab. 91 (2006), 2980–2985.
6. [6] Annweiler, C., Montero-Odasso, M., Schott, A.M., Berrut, G., Fantino, B., Beauchet, O., Fall prevention and vitamin D in the elderly: an overview of the key role of the non-bone effects. J. NeuroEng. Rehabil., 7, 2010, 50.
7. [7] Weatherall, M., A meta-analysis of 25 hydroxyvitamin D in older people with fracture of the proximal femur. N. Z. Med. J. 113 (2000), 137–140.
8. [8] Scragg, R., Seasonality of cardiovascular disease mortality and the possible protective effect of ultra-violet radiation. Int. J. Epidemiol. 10 (1981), 337–341.
9. [9] Simpson, R.U., Evidence for a specific 1,25-dihydroxyvitamin D3 receptor in rat heart (abstract). Circulation, 68, 1983, 239.
10. [10] Wang, L., Song, Y., Manson, J.E., Pilz, S., Marz, W., Michaelsson, K., Lundqvist, A., Jassal, S.K., Barrett-Connor, E., Zhang, C., Eaton, C.B., May, H.T., Anderson, J.L., Sesso, H.D., Circulating 2-hydroxy-vitamin D and risk of cardiovascular disease: a meta-analysis of prospective studies, circulation. Cardiovasc. Qual. Outcomes 5 (2012), 819–829.
11. [11] Garland, C.F., Kim, J.J., Mohr, S.B., Gorham, E.D., Grant, W.B., Giovannucci, E.L., Baggerly, L., Hofflich, H., Ramsdell, J.W., Zeng, K., Heaney, R.P., Meta-analysis of all-cause mortality according to serum 25-hydroxyvitamin D. Am. J. Public Health 104 (2014), e43–e50.
12. [12] Afzal, S., Brondum-Jacobsen, P., Bojesen, S.E., Nordestgaard, B.G., Genetically low vitamin D concentrations and increased mortality: mendelian randomisation analysis in three large cohorts. BMJ, 349, 2014, g6330.
13. [13] Norman, P.E., Powell, J.T., Vitamin D and cardiovascular disease. Circ. Res. 114 (2014), 379–393.
14. [14] Hsia, J., Heiss, G., Ren, H., Allison, M., Dolan, N.C., Greenland, P., Heckbert, S.R., Johnson, K.C., Manson, J.E., Sidney, S., Trevisan, M., Calcium/vitamin D supplementation and cardiovascular events. Circulation 115 (2007), 846–854.
15. [15] Jackson, R.D., LaCroix, A.Z., Gass, M., Wallace, R.B., Robbins, J., Lewis, C.E., Bassford, T., Beresford, S.A., Black, H.R., Blanchette, P., Bonds, D.E., Brunner, R.L., Brzyski, R.G., Caan, B., Cauley, J.A., Chlebowski, R.T., Cummings, S.R., Granek, I., Hays, J., Heiss, G., Hendrix, S.L., Howard, B.V., Hsia, J., Hubbell, F.A., Johnson, K.C., Judd, H., Kotchen, J.M., Kuller, L.H., Langer, R.D., Lasser, N.L., Limacher, M.C., Ludlam, S., Manson, J.E., Margolis, K.L., McGowan, J., Ockene, J.K., O'Sullivan, M.J., Phillips, L., Prentice, R.L., Sarto, G.E., Stefanick, M.L., Van Horn, L., Wactawski-Wende, J., Whitlock, E., Anderson, G.L., Assaf, A.R., Barad, D., Calcium plus vitamin D supplementation and the risk of fractures. N. Engl. J. Med. 354 (2006), 669–683.
16. [16] Newmark, H.L., Heaney, R.P., Calcium, vitamin D, and risk reduction of colorectal cancer. Nutr. Cancer 56:1 (2006), 1–2.
17. [17] Trivedi, D.P., Doll, R., Khaw, K.T., Effect of four monthly oral vitamin D3 (cholecalciferol) supplementation on fractures and mortality in men and women living in the community: randomised double blind controlled trial. BMJ, 326, 2003, 469.
18. [18] Stroder, J., Kasal, P., Phagocytosis in vitamin D deficient rickets. Klin. Wochenschr. 48 (1970), 383–384.
19. [19] Cannell, J.J., Vieth, R., Umhau, J.C., Holick, M.F., Grant, W.B., Madronich, S., Garland, C.F., Giovannucci, E., Epidemic influenza and vitamin D. Epidemiol. Infect. 134 (2006), 1129–1140.
20. [20] Camargo, C.A., Mansbach, J.M., Ginde, A.A., Vitamin D, childhood wheezing, asthma, and chronic obstructive pulmonary disease. Feldman, D., Adams, J., Pike, W., (eds.) Vitamin D, 2011, Elsevier Academic Press, Burlington, MA, 1999–2021.
21. [21] Jolliffe, D.A., Griffiths, C.J., Martineau, A.R., Vitamin D in the prevention of acute respiratory infection: systematic review of clinical studies. J. Steroid Biochem. Mol. Biol. 136 (2013), 321–329.
22. [22] Kroner, J.C., Sommer, A., Fabri, M., Vitamin D every day to keep the infection away?. Nutrients 7 (2015), 4170–4188.
23. [23] Wang, G., Mishra, B., Epand, R.F., Epand, R.M., High-quality 3D structures shine light on antibacterial, anti-biofilm and antiviral activities of human cathelicidin LL-37 and its fragments. Biochim. Biophys. Acta 1838 (2014), 2160–2172.
24. [24] Liu, P.T., Stenger, S., Li, H., Wenzel, L., Tan, B.H., Krutzik, S.R., Ochoa, M.T., Schauber, J., Wu, K., Meinken, C., Kamen, D.L., Wagner, M., Bals, R., Steinmeyer, A., Zugel, U., Gallo, R.L., Eisenberg, D., Hewison, M., Hollis, B.W., Adams, J.S., Bloom, B.R., Modlin, R.L., Toll-like receptor triggering of a vitamin D-mediated human antimicrobial response. Science 311 (2006), 1770–1773.
25. [25] Durr, U.H., Sudheendra, U.S., Ramamoorthy, A., LL-37, the only human member of the cathelicidin family of antimicrobial peptides. Biochim. Biophys. Acta 1758 (2006), 1408–1425.
26. [26] Greiller, C.L., Martineau, A.R., Modulation of the immune response to respiratory viruses by vitamin D. Nutrients 7 (2015), 4240–4270.
27. [27] Camargo, C.A. Jr., Ganmaa, D., Frazier, A.L., Kirchberg, F.F., Stuart, J.J., Kleinman, K., Sumberzul, N., Rich-Edwards, J.W., Randomized trial of vitamin D supplementation and risk of acute respiratory infection in Mongolia. Pediatrics 130 (2012), e561–e567.
28. [28] Murdoch, D.R., Slow, S., Chambers, S.T., Jennings, L.C., Stewart, A.W., Priest, P.C., Florkowski, C.M., Livesey, J.H., Camargo, C.A., Scragg, R., Effect of vitamin D3 supplementation on upper respiratory tract infections in healthy adults: the VIDARIS randomized controlled trial. JAMA 308 (2012), 1333–1339.
29. [29] Bergman, P., Lindh, A.U., Bjorkhem-Bergman, L., Lindh, J.D., Vitamin D and respiratory tract infections: a systematic review and meta-analysis of randomized controlled trials. PLoS One, 8, 2013, e65835.
30. [30] Glerup, Mikkelsen, K., Poulsen, L., Hass, E., Overbeck, S., Andersen, H., Charles, P., Eriksen, E.F., Hypovitaminosis D myopathy without biochemical signs of osteomalacic bone involvement. Calcif. Tissue Int. 66 (2000), 419–424.
31. [31] Dawson-Hughes, B., Serum 25-hydroxyvitamin D and functional outcomes in the elderly. Am. J. Clin. Nutr. 88 (2008), 537S–540S.
32. [32] Norman, A.W., Receptors for 1alpha,25(OH) 2D3: past, present, and future. J. Bone Miner. Res. 13 (1998), 1360–1369.
33. [33] Ceglia, L., Harris, S.S., Vitamin D and its role in skeletal muscle. Calcif. Tissue Int. 92 (2013), 151–162.
34. [34] Bischoff-Ferrari, H.A., Dawson-Hughes, B., Staehelin, H.B., Orav, J.E., Stuck, A.E., Theiler, R., Wong, J.B., Egli, A., Kiel, D.P., Henschkowski, J., Fall prevention with supplemental and active forms of vitamin D: a meta-analysis of randomised controlled trials. BMJ, 339, 2009, b3692.
35. [35] Gillespie, L.D., Robertson, M.C., Gillespie, W.J., Sherrington, C., Gates, S., Clemson, L.M., Lamb, S.E., Interventions for preventing falls in older people living in the community. Cochrane Database Syst. Rev., 9, 2012, CD007146.
36. [36] Cranney, A., Horsley, T., O'Donnell, S., Weiler, H., Puil, L., Ooi, D., Atkinson, S., Ward, L., Moher, D., Hanley, D., Fang, M., Yazdi, F., Garritty, C., Sampson, M., Barrowman, N., Tsertsvadze, A., Mamaladze, V., Effectiveness and safety of vitamin D in relation to bone health. Evid. Rep. Technol. Assess (Full Rep.), 2007, 1–235.
37. [37] Murad, M.H., Elamin, K.B., Abu Elnour, N.O., Elamin, M.B., Alkatib, A.A., Fatourechi, M.M., Almandoz, J.P., Mullan, R.J., Lane, M.A., Liu, H., Erwin, P.J., Hensrud, D.D., Montori, V.M., Clinical Review: the effect of vitamin D on falls: a systematic review and meta-analysis. J. Clin. Endocrinol. Metab. 96 (2011), 2997–3006.
38. [38] Aaron, J.E., Gallagher, J.C., Anderson, J., Stasiak, L., Longton, E.B., Nordin, B.E., Nicholson, M., Frequency of osteomalacia and osteoporosis in fractures of the proximal femur. Lancet 1 (1974), 229–233.
39. [39] Lips, P., van Schoor, N.M., The effect of vitamin D on bone and osteoporosis. Best Pract. Res. Clin. Endocrinol. Metab. 25 (2011), 585–591.
40. [40] Bischoff-Ferrari, H.A., Willett, W.C., Wong, J.B., Stuck, A.E., Staehelin, H.B., Orav, E.J., Thoma, A., Kiel, D.P., Henschkowski, J., Prevention of nonvertebral fractures with oral vitamin D and dose dependency: a meta-analysis of randomized controlled trials. Arch. Int. Med. 169 (2009), 551–561.
41. [41] Sawka, A.M., Ismaila, N., Cranney, A., Thabane, L., Kastner, M., Gafni, A., Woodhouse, L.J., Crilly, R., Cheung, A.M., Adachi, J.D., Josse, R.G., Papaioannou, A., A scoping review of strategies for the prevention of hip fracture in elderly nursing home residents. PLoS One, 5, 2010, e9515.
42. [42] DIPART, Patient level pooled analysis of 68 500 patients from seven major vitamin D fracture trials in US and Europe. BMJ, 340, 2010, b5463.
43. [43] Chung, M., Lee, J., Terasawa, T., Lau, J., Trikalinos, T.A., Vitamin D with or without calcium supplementation for prevention of cancer and fractures: an updated meta-analysis for the U. S. Preventive Services Task Force. Ann. Int. Med. 155 (2011), 827–838.
44. [44] Meyer, H.E., Holvik, K., Lips, P., Should vitamin D supplements be recommended to prevent chronic diseases?. BMJ, 350, 2015, h321.
45. [45] Scragg, R., Jackson, R., Holdaway, I.M., Lim, T., Beaglehole, R., Myocardial infarction is inversely associated with plasma 25-hydroxyvitamin D3 levels: a community-based study. Int. J. Epidemiol. 19 (1990), 559–563.
46. [46] Wareham, N.J., Jakes, R.W., Rennie, K.L., Schuit, J., Mitchell, J., Hennings, S., Day, N.E., Validity and repeatability of a simple index derived from the short physical activity questionnaire used in the European Prospective Investigation into Cancer and Nutrition (EPIC) study. Public Health Nutr. 6 (2003), 407–413.
47. [47] Lin, A.C., Lowe, A., Sidhu, K., Harrison, W., Ruygrok, P., Stewart, R., Evaluation of a novel sphygmomanometer, which estimates central aortic blood pressure from analysis of brachial artery suprasystolic pressure waves. J. Hypertens. 30 (2012), 1743–1750.
48. [48] Yamada, T., Demura, S., Relationships between ground reaction force parameters during a sit-to-stand movement and physical activity and falling risk of the elderly and a comparison of the movement characteristics between the young and the elderly. Arch. Gerontol. Geriatr. 48 (2009), 73–77.
49. [49] Verghese, J., Wang, C., Holtzer, R., Relationship of clinic-based gait speed measurement to limitations in community-based activities in older adults. Arch. Phys. Med. Rehabil. 92 (2011), 844–846.
50. [50] Bischoff-Ferrari, H.A., Giovannucci, E., Willett, W.C., Dietrich, T., Dawson-Hughes, B., Estimation of optimal serum concentrations of 25-hydroxyvitamin D for multiple health outcomes. Am. J. Clin. Nutr. 84 (2006), 18–28.
51. [51] Scragg, R., Sowers, M., Bell, C., Serum 25-hydroxyvitamin D, diabetes, and ethnicity in the Third National Health and Nutrition Examination Survey. Diabetes Care 27 (2004), 2813–2818.
52. [52] Black, P.N., Scragg, R., Relationship between serum 25-hydroxyvitamin D and pulmonary function in the third national health and nutrition examination survey. Chest 128 (2005), 3792–3798.
53. [53] Scragg, R., Sowers, M., Bell, C., Serum 25-hydroxyvitamin D, ethnicity, and blood pressure in the Third National Health and Nutrition Examination Survey. Am. J. Hypertens. 20 (2007), 713–719.
54. [54] Sohl, E., de Jongh, R.T., Heymans, M.W., van Schoor, N.M., Lips, P., Thresholds for Serum 25(OH)D Concentrations With Respect to Different Outcomes. J Clin Endocrinol Metab 100 (2015), 2480–2488.
55. [55] Ilahi, M., Armas, L.A., Heaney, R.P., Pharmacokinetics of a single, large dose of cholecalciferol. Am. J. Clin. Nutr. 87 (2008), 688–691.
56. [56] Becker, J., Schwartz, C., Saris-Baglama, R.N., Kosinski, M., Bjorner, J.B., Using item response theory (IRT) for developing and evaluating the Pain Impact Questionnaire (PIQ-6TM). Pain Med. 8:suppl. 3 (2007), S129–144.
57. [57] Yesavage, J.A., Geriatric depression scale. Psychopharmacol. Bull. 24 (1988), 709–711.
58. [58] Legerlotz, K., Smith, H.K., Hing, W.A., Variation and reliability of ultrasonographic quantification of the architecture of the medial gastrocnemius muscle in young children. Clin. Physiol. Funct. Imaging 30 (2010), 198–205.
59. [59] Quintana, D.S., Heathers, J.A., Kemp, A.H., On the validity of using the Polar RS800 heart rate monitor for heart rate variability research. Eur. J. Appl. Physiol. 112 (2012), 4179–4180.
60. [60] Schmitt, J., Wozel, G., The psoriasis area and severity index is the adequate criterion to define severity in chronic plaque-type psoriasis. Dermatology 210 (2005), 194–199.
61. [61] Wactawski-Wende, J., Kotchen, J.M., Anderson, G.L., Assaf, A.R., Brunner, R.L., O'Sullivan, M.J., Margolis, K.L., Ockene, J.K., Phillips, L., Pottern, L., Prentice, R.L., Robbins, J., Rohan, T.E., Sarto, G.E., Sharma, S., Stefanick, M.L., Van Horn, L., Wallace, R.B., Whitlock, E., Bassford, T., Beresford, S.A., Black, H.R., Bonds, D.E., Brzyski, R.G., Caan, B., Chlebowski, R.T., Cochrane, B., Garland, C., Gass, M., Hays, J., Heiss, G., Hendrix, S.L., Howard, B.V., Hsia, J., Hubbell, F.A., Jackson, R.D., Johnson, K.C., Judd, H., Kooperberg, C.L., Kuller, L.H., LaCroix, A.Z., Lane, D.S., Langer, R.D., Lasser, N.L., Lewis, C.E., Limacher, M.C., Manson, J.E., Calcium plus vitamin D supplementation and the risk of colorectal cancer. N. Engl. J. Med. 354 (2006), 684–696.
62. [62] Hathcock, J.N., Shao, A., Vieth, R., Heaney, R., Risk assessment for vitamin D. Am. J. Clin. Nutr. 85 (2007), 6–18.
63. [63] Sanders, K.M., Stuart, A.L., Williamson, E.J., Simpson, J.A., Kotowicz, M.A., Young, D., Nicholson, G.C., Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial. JAMA 303 (2010), 1815–1822.
64. [64] Hak, E., Rovers, M.M., Kuyvenhoven, M.M., Schellevis, F.G., Verheij, T.J., Incidence of GP-diagnosed respiratory tract infections according to age, gender and high-risk co-morbidity: the Second Dutch National Survey of General Practice. Fam. Pract. 23 (2006), 291–294.
65. [65] Ashworth, M., Charlton, J., Latinovic, R., Gulliford, M., Age-related changes in consultations and antibiotic prescribing for acute respiratory infections, 1995–2000. Data from the UK General Practice Research Database. J. Clin. Pharm. Ther. 31 (2006), 461–467.
66. [66] Kerse, N., Flicker, L., Pfaff, J.J., Draper, B., Lautenschlager, N.T., Sim, M., Snowdon, J., Almeida, O.P., Falls, depression and antidepressants in later life: a large primary care appraisal. PLoS One, 3, 2008, e2423.
67. [67] Therneau, T.M., Grambsch, P.M., Modeling Survival Data: Extending the Cox Model. 2000, Springer, New York.
68. [68] Looker, A.C., Dawson-Hughes, B., Calvo, M.S., Gunter, E.W., Sahyoun, N.R., Serum 25-hydroxyvitamin D status of adolescents and adults in two seasonal subpopulations from NHANES III. Bone 30 (2002), 771–777.
69. [69] Rockell, J.E., Skeaff, C.M., Williams, S.M., Green, T.J., Serum 25-hydroxyvitamin D concentrations of New Zealanders aged 15 years and older. Osteoporos Int. 17 (2006), 1382–1389.
70. [70] Salmon, P.J., Chan, W.C., Griffin, J., McKenzie, R., Rademaker, M., Extremely high levels of melanoma in Tauranga, New Zealand: possible causes and comparisons with Australia and the northern hemisphere. Australas. J. Dermatol. 48 (2007), 208–216.
71. [71] Nowson, C.A., Margerison, C., Vitamin D intake and vitamin D status of Australians. Med. J. Aust. 177 (2002), 149–152.
72. [72] Heaney, R.P., Davies, K.M., Chen, T.C., Holick, M.F., Barger-Lux, M.J., Human serum 25-hydroxycholecalciferol response to extended oral dosing with cholecalciferol. Am. J. Clin. Nutr. 77 (2003), 204–210.
73. [73] Ministry of Health, Mortality and Demographic Data 2011. 2014, Ministry of Health, Wellington, New Zealand.
74. [74] Ministry of Health, Hospital Events 2008/09 and 2009/10. 2012, Ministry of Health, Wellington, New Zealand.