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Table 4 Planned and ongoing large randomised controlled trials of vitamin D supplements with relevant prior 25-hydroxyvitamin D surveys

From: Assessment of research waste part 2: wrong study populations- an exemplar of baseline vitamin D status of participants in trials of vitamin D supplementation

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