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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