Vitamin D supplementation in older people (VDOP): Study protocol for a randomised controlled intervention trial with monthly oral dosing with 12,000 IU, 24,000 IU or 48,000 IU of vitamin D3

Table 1 Schedule of study procedures for VDOP

		Phone call 0	Visit 0	Visit 1	Phone call 1	Phone call 2	Visit 2	Phone call 3	Phone call 4	Visit 3	Phone call 5	Phone call 6	Visit 4	Phone call 7	Phone call 8	Visit 5
	Pre- Screening	Pre- Screening	Screening	Baseline visit	FUP^a 1	FUP^a 2	FUP^a 3	FUP^a 4	FUP^a 5	FUP^a 6	FUP^a 7	FUP^a 8	FUP^a 9	FUP^a 10	FUP^a 11	Final visit
Venue	PIC^a	Home	CARU^a	CARU^a	Home	Home	CARU^a	Home	Home	CARU^a	Home	Home	CARU^a	Home	Home	CARU^a
Month	−1	0	0	0	1	2	3	4	5	6	7	8	9	10	11	12
Identification	X
Pre-Screening		X
Informed consent			X
Venipuncture (screening)			X
Randomisation			X
Medical history, Demispan,, falls history and fracture risk				X
Demographics				X
TU&G^a test grip strength				X												X
DXA (total hip) weight height				X												X
Venipuncture (safety and biochemistry)				X			X			X			X			X
Urine sample				X			X			X			X			X
Physical exam and vital signs				X			X			X			X			X
Quality of Life			X				X			X			X			X
CalQuest			X							X						X
Sunshine exposure			X				X			X			X			X
Falls diaries				----------	----------	-------➔	X	---------	-------➔	X	---------	-------➔	X	---------	-------➔	X
Administer treatment				X	X	X	X	X	X	X	X	X	X	X	X
Check drug adherence					X	X	X	X	X	X	X	X	X	X	X	X

^a CARU Clinical Ageing Research Unit, FUP follow-up visit, PIC Patient Identification Centre, TU&G Time up and Go.

ISSN: 1745-6215