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Table 2 Inclusion, non-inclusion, and drop-out criteria

From: VITADIAL “Does correction of 25 OH-VITAmin D with cholecalciferol supplementation increase muscle strength in hemoDIALysis patients?”: study protocol for a randomized controlled trial

Inclusion criteria:

- Under hemodialysis for more than 3 months

- Aged over 18 years old

- Gave their consent

Non-inclusion criteria:

- Non-fluent French speaker

- Incapacity to provide consent or to answer questionnaires

- Pregnancy or breast feeding

- Cognitive impairment

- Bedridden or life expectancy <1 year

- Active cancer

- Uncontrolled hyperparathyroidism as defined by the K-DIGO (iPTH >9x normal laboratory maximal value), cinacalcet treatment or hypocalcemia <2.0 mmol/L or hypercalcemia >2.7mmol/L

- Past osteoporosis fracture

- Treatment with active vitamin D

- Unable to perform handgrip measurement

- 25OHD >50nmol/L without vitamin D treatment

- Cholecalciferol intolerance or allergy

Drop out criteria:

- 25OHD >50nmol/L after 12 months wash-out

- Hypercalcemia >2.7mmol/L

- Hyperparathyroidism (iPTH >9x normal laboratory maximal value) during wash-out or after randomization if patient is in the no treatment group

- Hypoparathyroidism (iPTH <3x normal laboratory lower value) in a patient receiving cholecalciferol

- Cholecalciferol intolerance or allergy

- Death, renal transplantation

- Pregnancy

- Consent withdrawal

- Renal recuperation allowing hemodialysis to stop

- Unability to perform handgrip