Effect of oral sodium bicarbonate supplementation on progression of chronic kidney disease in patients with chronic metabolic acidosis: study protocol for a randomized controlled trial (SoBic-Study)

Table 1 Visit and assessment schedule

	Screening period (4 weeks)							Treatment period (0 to 24 months)
		Day 0	Week 4	Week 8	Week 12	Week 20	Week 29	Week 38	Week 47	Week 60	Week 73	Week 86	Week 104
		Day 0	(± 2 days)	(± 2 days)	(± 2 days)	(± 5 days)	(± 5 days)	(± 5 days)	(± 5 days)	(± 10 days)	(± 10 days)	(± 10 days)	(± 10 days)
Visit	1	2	3	4	5	6	7	8	9	10	11	12	13
Informed consent		x
Inclusion/exclusion criteria	x	x
Randomization		x
Medical history		x											x
Concomitant medication		x	x	x	x	x	x	x	x	x	x	x	x
Physical examination		x											x
Body weight and height		x											x
Vital signs (BP, PR)		x	x	x	x	x	x	x	x	x	x	x	x
Laboratory test	x	x	x	x	x	x	x	x	x	x	x	x	x
Laboratory test: bone markers		x				x							x
Biobank sample		x				x			x		x		x
Urinalysis	x	x	x	x	x	x	x	x	x	x	x	x	x
24-hour urine collection	x^a	x^a	x			x			x				x
Urine pregnancy test ^b		x	x	x	x	x	x	x	x	x	x	x	x
Adverse events			x	x	x	x	x	x	x	x	x	x

^aTo be performed either at screening visit 1 or screening visit 2. prior to randomization; ^bfor females of childbearing age only. BP, blood pressure; PR,pulse rate.

ISSN: 1745-6215