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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