Background: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). Methods: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. Results: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. Conclusions: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.
Background: Chronic hemodialysis (HD) patients are at high risk of severe COVID-19 with a high risk of death. The organization of dialysis units to treat chronic HD patients with COVID-19 is demanding to prevent virus transmission both in COVID-free patients and the staff. These constraints may have an impact on the dialysis delivery to COVID-free HD patients. We report our experience in French NephroCare (NC) centers. Methods: We report retrospectively dialysis and nutritional indicators among COVID-free prevalent chronic HD patients’ cohort treated in French NC units from February 2020 to April 2020. The COVID-free HD patients were split into 2 subgroups for the analysis, Paris region and other regions because the incidence of COVID-19 was different according to the French regions. Results: The Paris region was the most impacted by COVID-19 with 73% of all the contaminations that occurred in French NC units (n = 118). The dialysis frequency was not reduced all over the NC regions. 2,110 COVID-free HD patients were split into 2 subgroups including Paris region (748 patients) and other regions (1,362 patients). The weekly treatment time decreased significantly in Paris region from February to April (723–696 min [p < 0.00001]) but remained stable in the other regions. The processed blood volume, KT/V, and convective volume declined significantly in the Paris region subgroup but not in other regions. The 3-month weight loss significantly increased in the whole group of patients whatever the region from 0.0 to 0.2% between February 2020 and April 2020 (p < 0.00001). Ultrafiltration rate (UFR) and the normalized proteic catabolic rate remained stable all along the period. The stepwise regression analysis identified February serum albumin level and April UFR as negatively associated with 3-month weight loss. Conclusion: HD delivery to COVID-free HD patients was negatively impacted in the Paris region because of the strong constraints on units’ organization related to the treatment of COVID-19+ HD patients and with a higher proportion of limited care/self-care units with less staff resources. The 3-month weight loss increase may be related to the suppression of intradialytic snack that impacted mostly the more malnourished patients or patients with lower interdialytic weight gain. These consequences of the COVID-19 crisis on COVID-free HD patients must be recognized and corrected to prevent further deleterious effects on patients’ outcomes.
Whether active fluid management prospectively improves hemodialysis outcomes is today more unknown than ever.1 Historically, the “Centre de Rein Artificiel” in Tassin/France has been recognized for strictly “probing dry weight,” which was placed in context with blood pressure control and excellent survival.2 We aimed at providing an update on fluid management in Tassin, hypothesizing that the mortality rate of the 2000 to 2014 Tassin incident cohort would be superior to that in the Dialysis Outcomes and Practice Patterns Study (for methodology, see the Supplementary Methods).
L’hémodialyse (HD) Longue Nocturne (HDLN) intermittente permet de combiner dialyse et sommeil. Ses avantages cliniques sont une vitesse d’ultrafiltration réduite, un meilleur contrôle de la volémie avec amélioration de la tolérance des séances et des performances cardiaques, une phosphatémie et des moyennes molécules mieux épurées et une meilleure survie dans les études de cohortes. La qualité de vie n’est pas altérée par la longueur des séances et elle s’améliore quand elle n’est pas optimale lors du transfert de l’HD standard vers l’HDLN. La qualité du sommeil n’est parfois perturbée mais elle n’est pas une cause importante de sortie du programme. La pérennité d’un programme d’HDLN passe par les volontés conjointes médicales et managériales, la sélection des patients stables, le respect des horaires et de la durée de séances, indispensable à la dialyse de sommeil. Les autorités de santé doivent jouer un rôle pour permettre cette modalité dans des conditions financières acceptables. L’information au patient de l’existence de l’HDLN avant le stade de la dialyse est essentielle, aidée par le témoignage des pairs. Les sociétés savantes doivent soutenir la recherche et l’information aux néphrologues. Enfin les conditions architecturales favorisant l’intimité et le sommeil sont une clé de réussite du programme.
Background Muscle strength decreases as kidney 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 kidney disease (CKD) population, but low 25OHD levels have been associated with poor muscle strength. We present in this article the protocol of an ongoing study named VITADIAL testing if cholecalciferol supplementation in hemodialysis patients with low 25OHD improves their muscle strength. Methods/design VITADIAL is a 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-month 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. Fifty-four patients are needed in each group to meet our main objective. Discussion In the general population, around 30 randomized studies analyzed the effects of vitamin D supplementation on muscle strength. These studies had very different designs, sizes, and studied population. Globally, these studies and the meta-analysis of studies favor a beneficial effect of vitamin D supplementation on muscle strength, but this effect is mainly found in the subgroup of aged patients and those with the lowest 25OHD concentrations at inclusion. We reported a positive independent association between 25OHD and handgrip strength in a population of 130 hemodialysis patients in a dose-dependent manner. In our cohort, a plateau effect was observed above 75 nmol/L. Only two randomized studies analyzed the effect of native vitamin D supplementation on muscle strength in hemodialysis patients, but unfortunately, these two studies were underpowered. VITADIAL is a trial specifically designed to assess whether cholecalciferol might benefit to hemodialysis patient’s muscle strength. Trial registration ClinicalTrials.gov NCT04262934 . Registered on 10 February 2020 - Retrospectively registered.
