Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT04262934
Eligibility Criteria:
* 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
* Exclusion 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04262934
Study Brief:
Protocol Section:
NCT04262934