Cholecalciferol and muscle strength in hemodialysis patients: results from the randomized VITADIAL trial

Many factors contribute to muscle impairment during chronic kidney disease, among which vitamin D deficiency has been implicated. The aim of this study was to analyze whether cholecalciferol supplementation in hemodialysis patients with low 25-hydroxyvitamin vitamin D (25OHD) concentrations could improve handgrip strength (HGS).

VITADIAL (Does Correction of 25 OH-VITAmin D With Cholecalciferol Supplementation Increase Muscle Strength in HemoDIALysis Patients?) is a prospective open-labeled French multicenter study in which chronic hemodialysis patients with a 25OHD ≤50 nmol/L were randomized to receive monthly oral 100 000 IU cholecalciferol or no vitamin D treatment during 6 months to assess whether cholecalciferol supplementation in vitamin D-deficient hemodialysis patients improves muscle strength as measured with HGS. The main objective of the study was to analyze whether a 6-month period of oral cholecalciferol improved the muscle strength of hemodialysis patients with low 25OHD levels.

Within the 270 hemodialysis patients from 10 hemodialysis centers included in the study, 143 patients with 25OHD ≤50 nmol/L were randomized: 70 were allocated to the cholecalciferol group and 73 to the control group. The two groups were comparable at inclusion. The cholecalciferol supplemented group's 25OHD rose to 89.78 ± 33.43 nmol/L at 6 months and remained ≤50 nmol/L for most patients in the control group, but HGS did not change significantly between randomization and end of the study in both groups (0.07 ± 3.40 kg and -0.19 ± 3.35 kg, respectively, P-value .682). No difference was found in terms of either autonomy or frailty.

This highly powered study did not find any effect of cholecalciferol supplementation in muscle strength of hemodialysis patients with low 25OHD.Trial registration: ClinicalTrials, NCT04262934. Registered 10 February 2020. Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04262934.