Table 1.
Study Characteristics of Randomized Controlled Trials Reporting Effects of Vitamin D Treatment on Risk of Fractures and Falls
Source | Location | No. of participants | Interventions | FU duration, mo | Age, yr | Women, % | Outcomes reported | No. of events |
---|---|---|---|---|---|---|---|---|
Appel et al. (2021) [7] | US | 688 | 1,000, 2,000, or 4,000 IU of vitamin D3 per day for dose-finding stage | 24 | 77.2 | 43.6 | Fall | 365 |
1,000 IU/day for confirmatory stage | ||||||||
Bischoff-Ferrari et al. (2020) [25] | Switzerland | 2,157 | 2×2×2 factorial design | 36 | 74.9 | 61.7 | Fracture | 256 |
2,000 IU/day of vitamin D3 and calcium supplement 500 mg/day, 1 g/day of omega-3s, and a strength-training exercise program; vitamin D3 and omega-3s; vitamin D3 and exercise; vitamin D3 alone; omega-3s and exercise; omega-3s alone; exercise alone; or placebo | ||||||||
LeBoff et al. (2020) [10] | US | 25,871 | 2×2 factorial design | 63.6 | 67.1 | 51 | Fall | 2,329 |
2,000 IU/day of vitamin D3 and calcium supplements and/or omega-3s 1 g/day or respective placebos | ||||||||
Khaw et al. (2017) [26] | New Zealand | 5,110 | Initial oral dose of 200,000 IU vitamin D3 followed by monthly 100,000 IU vitamin D3 or equivalent placebo | 41 | 65.9 | 42 | Fracture | 2,638 |
Fall | ||||||||
Levis et al. (2017) [27] | US | 130 | 4,000 IU per day of vitamin D3 or placebo | 9 | 72.4 | 0 | Fall | 19 |
Hin et al. (2017) [28] | UK | 305 | 4,000, 2,000 IU per day of vitamin D3 or placebo | 12 | 71 | 49 | Fall | 48 |
Imaoka et al. (2016) [29] | Japan | 91 | 900 IU/day of vitamin D or placebo | 9 | 82 | 75.8 | Fall | 15 |
Cangussu et al. (2016) [30] | Brazil | 160 | 1,000 IU/day of vitamin D3 or placebo | 12 | 59 | 100 | Fall | 56 |
Baron et al. (2015) [23] | US | 2,259 | Partial 2×2 factorial design | 60 | 58 | 15 | Fracture | 119 |
1,000 IU per day of vitamin D3, 1,200 mg/ day of calcium carbonate, both, or neither | ||||||||
Uusi-Rasi et al. (2015) [31] | Finland | 409 | Placebo without exercise, vitamin D3 (800 IU/day) without exercise, placebo and exercise, and vitamin D3 (800 IU/day) and exercise | 24 | 74 | 100 | Fall | 26 |
Hansen et al. (2015) [32] | US | 230 | Daily white and twice monthly yellow placebo, daily 800 IU vitamin D3 and twice monthly yellow placebo, and daily white placebo and twice monthly 50,000 IU vitamin D3 (n=79) | 12 | 61 | 100 | Fall | 45 |
Wood et al. (2014) [33] | UK | 305 | 400 or 1,000 IU per daily of vitamin D3 or placebo | 12 | 63.8 | 100 | Fall | 58 |
Prentice et al. (2013) [34] | US | 36,282 | 1,000 mg elemental calcium carbonate plus 400 IU of vitamin D3 daily or placebo | 86 | 65 | 100 | Fracture | 4,260 |
Witham et al. (2013) [35] | UK | 159 | 100,000 IU of oral cholecalciferol every 3 months or placebo | 12 | 77 | 50 | Fall | 82 |
Glendenning et al. (2012) [36] | Australia | 686 | 150,000 IU every 3 months of oral cholecalciferol or placebo | 9 | 76 | 100 | Fall | 191 |
Salovaara et al. (2010) [24] | Finland | 3,195 | 800 IU of cholecalciferol and 1,000 mg of calcium carbonate or control without placebo | 36 | 67 | 100 | Fracture | 172 |
Sanders et al. (2010) [19] | Australia | 137 | 500,000 IU of oral cholecalciferol annually or placebo | 60 | 76 | 100 | Fracture | 306 |
Fall | 1,606 | |||||||
Karkkainen et al. (2010) [37] | Finland | 3,139 | 800 IU of cholecalciferol and 1,000 mg of calcium carbonate or control without placebo | 36 | 67 | 100 | Fall | 1,645 |
Pfeifer et al. (2009) [38] | Germany | 242 | 1,000 mg of calcium or 1,000 mg of calcium plus 800 IU of vitamin D3 per day | 12 | 77 | 100 | Fall | 124 |
Bischoff-Ferrari et al. (2006) [39] | US | 445 | 700 IU of vitamin D3 plus 500 mg of calcium citrate per day or placebo | 36 | 71 | 55 | Fall | 170 |
Porthouse et al. (2005) [40] | UK | 3,314 | Daily oral supplementation using 1,000 mg calcium with 800 IU cholecaliferol or control without placebo | 25 | 77 | 100 | Fracture | 103 |
Grant et al. (2005) [41] | UK | 5,292 | 800 IU daily oral vitamin D3, 1,000 mg calcium, oral vitamin D3 plus calcium (1,000 mg per day), or placebo | 24 | 77 | 100 | Fracture | 408 |
Fall | 415 | |||||||
Larsen et al. (2005) [42] | Denmark | 9,605 | 1,000 mg of calcium carbonate and 400 IU of vitamin D3 daily or control | 42 | 74 | 60.1 | Fall | 913 |
Trivedi et al. (2003) [22] | UK | 2,686 | 100,000 IU oral vitamin D3 or matching placebo every 4 months | 60 | 74 | 24.1 | Fracture | 268 |
Fall | 515 | |||||||
Chapuy et al. (2002) [21] | France | 583 | 800 IU of vitamin D3 plus 1,200 mg calcium carbonate or placebo | 24 | 85 | 100 | Fracture | 105 |
Fall | ||||||||
Meyer et al. (2002) [43] | Norway | 1,144 | Ordinary cod liver oil (400 IU of vitamin D3) or cod liver oil where vitamin D was removed | 24 | 85 | 75 | Fracture | 145 |
Pfeifer et al. (2000) [18] | Germany | 148 | 1,200 mg of calcium carbonate or 1,200 mg of elemental calcium and 800 IU of vitamin D3 | 12 | 74 | 100 | Fracture | 9 |
Fall | 35 | |||||||
Peacock et al. (2000) [44] | US | 438 | 750 mg calcium citrate plus 600 IU of vitamin D3 or placebo | 48 | 75 | 71.7 | Fracture | 56 |
Komulainen et al. (1998) [45] | Finland | 464 | 300 IU/day of vitamin D3 or placebo | 120 | 53 | 100 | Fracture | 27 |
Dawson-Hughes et al. (1997) [46] | US | 389 | 500 mg of calcium plus 700 IU of vitamin D3 per day or placebo | 36 | 71 | 54.7 | Fracture | 37 |
Lips et al. (1996) [47] | Belgium | 2,578 | Vitamin D3, 400 IU in one tablet daily, or placebo | 42 | 80 | 74.3 | Fracture | 267 |
Chapuy et al. (1994) [20] | France | 3,270 | 1–2 g calcium daily in the form of tricalcium phosphate, together with 800 IU cholecalciferol or placebo | 18 | 72 | 100 | Fracture | 563 |
IU, international unit.