Background
Methods
Literature searches
Trial classification
Vitamin D status survey data
Analyses
Results
Baseline 25OHD in randomised controlled trials
Study | Clinical endpoint | Endpoint type | Study Size (N) | 25OHD Assay | Mean/Median 25OHD (SD) (nmol/L)a | Result of Trialb |
---|---|---|---|---|---|---|
Brooke 1980 [44] | Newborn outcomes | Secondary | 126 | CBP | 11 (1) | Benefit |
Chapuy 1994 [21] | Fracture | Primary | 3270 | CBP | 20 (14) | Benefit |
Pfeifer 2000 [45] | Risk of fall | Secondary | 148 | Nicholls | 19 (10) | Neutral |
Chapuy 2002 [46] | Fracture | Secondary | 583 | Incstar | 22 (16) | Neutral |
Bischoff 2003 [47] | Risk of fall | Primary | 122 | Nicholls | 23 (N/A) | Neutral |
Martineau 2011 [48] | Tuberculosis sputum culture conversion | Primary | 126 | LCMS/MS | 21 (20) | Neutral |
Mosayebi 2011 [49] | Multiple sclerosis disability score | Primary | 59 | IDS | 25 (7) | Neutral |
Amestejani 2012 [50] | Atopic dermatitis | Primary | 60 | Biosource | 24 (5) | Benefit |
Schreuder 2012 [51] | Pain | Primary | 84 | Diasorin | 20 (10) | Neutral |
Mozaffari-Khosravi 2013 [52] | Depression score | Primary | 120 | IDS | 23 (N/A) | Benefit |
Hossain 2014 [53] | Pregnancy outcomes | Primary | 200 | Immunoassay | 13 (N/A) | Neutral |
Bhan 2015 [54] | All-cause mortality | Secondary | 105 | LCMS/MS | 22 (7) | Neutral |
Study | 25OHD threshold (nmol/L) | Subgroup Resulta | Comparison to primary analysisa |
---|---|---|---|
Jackson 2006 [33] | 32.2 | Neutral | Same |
Jorde 2008 [55] | 40 | NR | N/Ab |
Wejse 2009 [56] | 75 | Neutral | Same |
Martineau 2011 [48] | 20 | Neutral | Same |
Rastelli 2011 [57] | 50 | Neutral | Samec |
Kjaergaard 2012 [58] | 25 | Neutral | Same |
Lehouck 2012 [59] | 25 | Neutral | Sameb |
Murdoch 2012 [60] | 50 | Neutral | Same |
Abou-Raya 2013 [61] | 25 | Benefit | Same |
McAlindon 2013 [62] | 37.5 | Neutral | Same |
Amrein 2014 [63] | 30 | Neutral | Sameb |
Lopez-Torres Hidalgo 2014 [64] | 80 | Neutral | Same |
Tran 2014 [65] | 50 | Neutral | Same |
Turner 2014 [66] | 50 | Neutral | Same |
Baron 2015 [36] | 57.9 | Neutral | Same |
Martineau 2015 [67] | 50 | Benefit | Differentd |
Miskulin 2015 [68] | 37.5 | Neutral | Same |
Sandoughi 2015 [69] | 50 | Neutral | Same |
Tukvadze 2015 [70] | 25 | Neutral | Same |
Large randomised controlled trials and prior 25OHD surveys
Trial | Survey identified | |||||||
---|---|---|---|---|---|---|---|---|
Reference/ Country | Trial characteristixcs | Baseline 25OHD (nmol/L) /Assaya | Cites Prior 25OHD Survey (S)/ Prior SR (PSR) /Any SR (ASR) | Recruit-ment started | Survey Date | Group surveyed | 25OHD [mean (SD)] (nmol/L)/Assaa | Survey Referenceb |
Chapuy 1994 [21] France | N = 3270 100% Female Mean age 84y | Subg 20 CPB | S:Yes Chapuy 1987 PSR:Noe ASR:No | NS | 1984 | Men and women Mean age 74-75y | CPB | Chapuy 1987 [71] |
Outpatients | 23 (10) | |||||||
Long stay hospital | 11 (6) | |||||||
Lips 1996 [22] Netherlands | N = 2578 74% Female Mean age 80y | Subg 27 HPLC | S:Yes Lips 1987 PSR:Noe ASR:No | 1988 | NS | Men and women Mean age 76y | CPB | Lips 1987 [72] |
Hip fracture patients | 10.0 (5.7) | |||||||
Apartment dwellers | 17.8 (7.3) | |||||||
1984–5 | CPB | Lowik 1990 [73] | ||||||
Men 65-79y | 21.6 (10.3) | |||||||
Women 65-79y | 20.5 (8.6) | |||||||
NS | Men and women Mean age 81-84y | CPB | Lips 1988 [74] | |||||
Nursing home | 12.7 (4.8) | |||||||
Aged people home | 12.9 (7.2) | |||||||
Meyer 2002 [23] Norway | N = 1144 76% Female Mean age 85y | Subg 49 HPLC | S:Yes Mowe 1998 PSR:Noe ASR:Yes | 1995 | 1989 | Men and women Mean age 78-80y Hospital patients | HPLC | Mowe 1998 [75] |
Men | 40.4 (23.2) | |||||||
Women | 37.5 (22.6) | |||||||
Home-living | ||||||||
Men | 59.6 (28.9) | |||||||
Women | 48.5 (20.3) | |||||||
1989 | CPB | Nes 1993 [76] | ||||||
Men 75-76y | 24.1 (10.1) | |||||||
Women 75-76y | 25.9 (11.2) | |||||||
Trivedi 2003 [37] UK | N = 2686 24% Female Mean age 75y | ND | S:No PSR:Noe ASR:No | 1996 | 1994-5 | Men and women | Incstar | Finch 1998 [77] |
Free-living 65y+ | 55.5 (26.9) | |||||||
Institution 65+ | 32.8 (15.7) | |||||||
Larsen 2004 [24] Denmark | N = 9605 60% Female Mean age 75y | Subg 36 Diasorin | S:Yes Lund 1979 PSR:Noe ASR:Yes | 1995 | Pre 1979 | Men and women | CPB | Lund 1979 [78] |
61-93y | 26.8 (12.4) | |||||||
1989 | Men and women | CPB | van der Wielen 1995 [14] | |||||
75-81y | Men 24 Women 22 | |||||||
Grant 2005 [29] UK | N = 5292 85% Female Mean age 77y | Subg 38 HPLC | S:No PSR:Yes ASR:Yes | 1999 | 1994–5 | Men and women | Incstar | Finch 1998 [77] |
Free-living 65y+ | 55.5 (26.9) | |||||||
Institution 65+ | 32.8 (15.7) | |||||||
Porthouse 2005 [38] UK | N = 3314 100% Female Mean age 77y | ND | S:No PSR:No ASR:No | 2001 | 1994–5 | Women | Incstar | Finch 1998 [77] |
Free-living 65y+ | 51.7 (24.7) | |||||||
Institution 65+ | 32.5 (15.5) | |||||||
Jackson 2006 [33] USA | N = 36,282 100% Female Mean age 62y | Subg 48 Liaison | S:No PSR:Noe ASR:Yes | 1995 | 1988-94 | Men and women | LC-MS/MS equivalent | Schleicher 2016c [79] |
40-59y | 60.1 (58.7,61.5) | |||||||
≥60y | 58.4 (57.4,59.5) | |||||||
All females | 59.2 (57.9,60.6) | |||||||
Law 2006 [34] UK | N = 3717 76% Female Mean age 85y | Subg 47 IDS | S:No PSR:No ASR:No | 2000 | 1994–5 | Men and women | Incstar | Finch 1998 [77] |
Institution 65+ | 32.8 (15.7) | |||||||
Lyons 2007 [39] UK | N = 3440 76% Female Mean age 84y | ND | S:No PSR:No ASR:Yes | 1999 | 1994–5 | Men and women | Incstar | Finch 1998 [77] |
Institution 65+ | 32.8 (15.7) | |||||||
Smith 2007 [35] UK | N = 9440 54% Female Mean age 79y | Subg 43 Nicholls | S:No PSR:No ASR:Yes | 1998 | 1994–5 | Men and women | Incstar | Finch 1998 [77] |
Free-living 65y+ | 55.5 (26.9) | |||||||
Institution 65+ | 32.8 (15.7) | |||||||
Lappe 2008 [25] USA | N = 5201 100% Female Median age 19y | ND | S:Yes Gordon 2004 PSR:No ASR:No | 2001 | 2001–3 | Boys and girls | Nichols | Gordon 2004 [80] |
11-18y | ||||||||
Summer | 49.8 (21.3) | |||||||
Winter | 38.2 (18.8) | |||||||
2001–2 | Males and females | LC-MS/MS equivalent | Schleicher 2016 [79] | |||||
12-19y | 63.0 (60.8,65.2) | |||||||
20-39y | 62.8 (60.6,64.9) | |||||||
1988–94 | Males and females | LC-MS/MS equivalent | Schleicher 2016c [79] | |||||
12-19y | 66.2 (64.1,68.4) | |||||||
20-39y | 64.4 (62.8,66.0) | |||||||
Salovaara 2010 [30] Finland | N = 3432 100% Female Mean age 67y | Subg 50 Diasorin | S:No PSR:No ASR:Yes | 2002 | 2000–1 | Women | Incstar | Kauppi 2009 [81] |
Mean age 53y Age range 30-97y | 45.2 (26.4) | |||||||
Sanders 2010 [26] Australia | N = 2258 100% Female Mean age 76y | Subg 50 Diasorin | S:Yes Pasco 2001 PSR:No ASR:Yes | 2003 | 1994–7 | Women | Incstar | Pasco 2001 [82] |
60-79y | 62 (31.7) | |||||||
80y+ | 53 (26.8) | |||||||
Punthakee 2012 [42] Multinational | N = 1221 41% Female Mean age 67y | ND | S: No PSR: Yes ASR:Yes | 2009 | ||||
Baron 2015 [36] USA | N = 2259 37% Female Mean age 58y | 61 IDS | S:No PSR:Noe ASR:Yes | 2004 | 2001-2 | Men and women | LC-MS/MS equivalent | Schleicher 2016c [79] |
40-59y | 62.4 (59.9,64.8) | |||||||
≥60y | 60.4 (58.0,62.9) | |||||||
Cooper 2016 [27]d UK | N = 1134 100% Female Mean age 31y | 47 Liaison | S:Yes Javaid 2006 PSR:Noe ASR:Yes | 2008 | 1991-2 | Pregnant women | IDS | Javaid 2006 [83] |
Mean 27y | 18% < 26.5 31% 26.5–50 52% > 50 | |||||||
2008–12 | Women 19 - 64y | Liaison 47.3 | National Diet and Nutrition Survey 2014. [84] | |||||
ViDA 2017 [28]d New Zealand | N = 5110 42% Female Mean age 66y | 63 LCMS/MS | S:Yes Rockwell 2006 PSR:Yes ASR:Yes | 2011 | 1996–7 | Men 45-64y/65y+ | 52/55 | Rockell 2006 [85] |
Women 45-64y/65y+ | 45/43 Diasorin | |||||||
2008–9 | Men and women | 61/63/66/62 | Adult nutrition survey 2009 [86] | |||||
45-54y/55-64y/65-74y/≥75y | LCMS/MS |
Trial | Survey identified | ||||||
---|---|---|---|---|---|---|---|
Trial/Country | Trial details | Cites 25OHD Survey (S)/ Systematic Review (SR) | Recruitment started | Survey Date | Group surveyed | 25OHD[mean/median(SD)] (nmol/L)/Assay | Survey Referencea |
D-Health Australia | N = 21,315, 5y 60,000 IU D3 monthly v placebo Men/women 60-84y ACTRN12613000743763 | S:Yes Tran 2012 pilot PSR:Yes ASR:Yes | 2014 | 2010–1 | Men and women | 41.7 (13.5) | Tran 2012 [87] Waterhouse 2015 [88] |
Mean age 72y | Liaison | ||||||
2011–2 | Men and Women | 68.9/69.8/68.6 | Australian health survey 2011–2 [89] | ||||
55-64y/65-74y/>75y | LCMS/MS | ||||||
DO-HEALTH 5 countries in Europe | N = 2152, 3y 2000 IU/d D3 v placebo Men/women ≥70y NCT01745263 | S:NDA PSR:NDA ASR: NDA | 2012 | ||||
FIND Finland | N = 2495, 5y 1600 IU/d D3 v 3200 IU/d D3 v placebo Men ≥60y, women ≥65y NCT01463813 | S:Yes Hurskainen 2012 PSR:No ASR:Yes | 2012 | 1998- 2001 | Men and women | 43.4 (17.6) | Hurskainen 2012 [90] |
Mean age 62.9y | HPLC | ||||||
Recruitment stopped early had aimed for 18,000 | 2003–5 | Men and women | 64.8 (17.4) | Salminen 2015 [91] | |||
Mean age 73.5y | IDS | ||||||
2011–2 | Men and women | 58.6 (9.3) | Carlberg 2013 [92] | ||||
Mean age 66.6y | HPLC | ||||||
TIPS-3 10 countries in Africa, Asia, South/ North America | N = 5000, 5y 60,000 IU D3 3 monthly v placebo Men ≥55y, women ≥60y NCT01646437 | S:NDA PSR:NDA ASR:NDA | 2012 | ||||
VIDAL UK | N = 1600, 2y 100,000 IU D3 monthly v placebo Men and women 65-84y ISRCTN46328341 Feasibility trial. Full trial (n = 20,000) not funded | S:Yes Hirani 2005 PSR:Yes ASR:Yes | 2012 | 2000 | Private households | Diasorin | Hirani 2005 [93] |
Men 65-79y/80+ | 58 (27)/48 (24) | ||||||
Women 65-79y/80+ | 49 (25)/45 (20) | ||||||
Institutions | |||||||
Men 65-79y/80+ | 40 (24)/37 (20) | ||||||
Women 65-79y/80+ | 37 (18)/37 (19) | ||||||
VITAL US | N = 25,874, 5y 2000 IU/d D3 v placebo Men ≥50y, women ≥55y NCT01169259 | S:Yes Looker 2002 PSR:Yes ASR:Yes | 2010 | 1988–1994 | Winter, lower latitude | Diasorin | Looker 2002 [94] |
Women 40-80y+ | 61.6–59.6 | ||||||
Men 40-80y+ | 70.6–68.7 | ||||||
Summer, higher latitude | |||||||
Women 40-80y+ | 68.6–61.8 | ||||||
Men 40-80y+ | 78.8–69.5 | ||||||
2005–2010 | Men and women | LC-MS/MS equivalent | Schleicher 2016b [79] | ||||
40-59y | 60.1–68.7 | ||||||
≥60y | 59.4–72.6 | ||||||
1988–1994 | Men and women | LC-MS/MS equivalent | Schleicher 2016b [79] | ||||
40-59y | 60.1 (58.7,61.5) | ||||||
≥60y | 58.4 (57.4,59.5) | ||||||
CAPS US | N = 2303, 5y 2000 IU D3 and 1500 mg calcium daily v calcium Women ≥55y NCT01052051 | S:NDA PSR:NDA ASR:NDA | 2009 | 2005–2010 | Men and women | LC-MS/MS equivalent | Schleicher 2016b [79] |
40-59y | 60.1–68.7 | ||||||
≥60y | 59.4–72.6 | ||||||
All females | 60.9–69.1 |