A Phase 3 interventional study of Cholecalciferol 100.000 UI administration and No vitamin D administration in hemoDIALysis Patients, sponsored by Institut Phoceen de Nephrologie. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-11.
Sponsored by Institut Phoceen de Nephrologie · Phase 3, Interventional, and Treatment
Muscle strength decreases as renal failure progresses. Low muscle strength affects more than 50% of hemodialysis patients and leads to daily life activities impairment. In the general population, numerous studies have linked low 25OH-vitamin D (25OHD) concentrations to the loss of the muscle strength and low physical performances. Data on native vitamin D and muscle function are scarce in the chronic renal failure (CKD) population, but low 25OHD levels have been associated with poor muscle strength. In this protocol of an ongoing study named VITADIAL testing if cholecalciferol supplementation in hemodialysis patients with low 25OHD improve their muscle strength.
Prospective open randomized French multicenter study. All patients will have 25OHD levels ≤50nmol/L at randomization. One group will receive 100 000 UI cholecalciferol once a month during 6 months, the other group will receive no treatment during 6 months.
In order to randomize patients with 25OHD ≤50nmol/L, supplemented patients will undergo a 3 months wash-out period renewable 3 times (maximum of 12 months wash-out) until 25OHD reaches a level≤50nmol/L.
The main objective of this study is to analyze if a 6 months period of oral cholecalciferol (i.e. native vitamin D) supplementation improves muscle strength of hemodialysis patients with low 25OHD vitamin D levels. Muscle strength will be assessed at 0, 3 and 6 months, by handgrip strength measured with a quantitative dynamometer.
Secondary objectives are 1) to analyze 25OHD plasma levels after vitamin D wash-out and/or supplementation, as well as factors associated with 25OHD lowering speed during wash-out and 2) to analyze if this supplementation improves patient's autonomy, reduces frailty risk and improves quality of life.
This is the only study on the registry with Institut Phoceen de Nephrologie as lead sponsor.
Counted across the registry records on this site, refreshed daily.
under hemodialysis for more than 3 months
Non-inclusion criteria :
25OHD>50nmol/L after 12 months wash-out
Arm A : Cholecalciferol 100.000 UI - oral - every month
Drug: Cholecalciferol 100.000 UI administration
Arm B : No vitamin D administration
Other: No vitamin D administration
One oral Administration - Every month
No vitamin D administration
Muscle strength evaluation after 6 months period after cholecalciferol or no vitamin D treatment
Muscle strength will be assessed by handgrip strength measured with a quantitative dynamometer
Time frame: At 6 months after randomization
Patient's autonomy after 6 months period of oral cholecalciferol
Katz Index of Independence in Activities of Daily Living (ADL)
Time frame: At 6 months post randomization (for patients treated)
Patient's frailty risk after 6 months period of oral cholecalciferol
The Frail Non-Disabled (FiND) Questionnaire
Time frame: At 6 months post randomization (for patients treated)
Patient's quality of life after 6 months period of oral cholecalciferol
Kidney Disease Quality of Life (KDQOL-SFtm) Questionnaire
Time frame: At 6 months post randomization (for patients treated)
Plan to share: No
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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