Biochemical Parameters After Cholecalciferol Repletion in Hemodialysis: Results From the VitaDial Randomized Trial

Massart, Annick; Debelle, Frédéric; Racapé, Judith; Gervy, Christine; Husson, Cécile; D'haene, Michel; Wissing, Karl Martin; Nortier, Joëlle

doi:10.1053/j.ajkd.2014.04.020

Cited by 59 publications

(41 citation statements)

References 39 publications

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“…43 Potential harms with nutritional vitamin D supplementation include hypercalcemia, hyperphosphatemia, and extraskeletal ossification. In our study, in which 80% or more were concomitantly treated with VDRAs, there were no significant changes in calcium or phosphorus, and this is consistent with all of the other RCTs in patients on hemodialysis, 19,[22][23][24][25][26][27]31,[33][34][35] including one study that administered 200,000 IU of cholecalciferol weekly for 3 weeks. 27 Raising the possibility that there may be harmful outcomes associated with excess nutritional vitamin D administration, an RCT in community dwelling elderly women treated with a one-time dose of 500,000 units of ergocalciferol or placebo found a 15% increase in falls and a 26% increase in fractures in the ergocalciferol arm at 1 year.…”

Section: Discussionsupporting

confidence: 88%

“…There have been ten previous RCTs with sample size $30 patients and follow-up $8 weeks that have assessed the effects of nutritional vitamin D or calcifediol supplementation in patients on dialysis on iPTH, 19,[22][23][24][25][26][27]31,[33][34][35] and all but one small study 33 is consistent with the present study in finding no effect on iPTH. An absence of effect of nutritional vitamin D on iPTH has also been found in stage IV CKD, 36,37 while at earlier stages of CKD, there appears to be a reduction in iPTH with nutritional vitamin D. The conclusion from a Cochrane evidence review, published in 2009 before many of the above-mentioned trials were completed, concluded that vitamin D is effective in suppressing iPTH, although (not obvious from the abstract) this statement pertains to VDRAs and not to nutritional vitamin D. 38 The results of observational studies lead one to believe that there is a reduction in iPTH in patients on hemodialysis with nutritional vitamin D supplementation, 6,8,18,39 although these studies used historical controls and are limited by other biases inherent with a nonrandomized design.…”

Section: Discussionsupporting

confidence: 82%

“…Nonrandomized observational studies 6,[18][19][20] and small randomized clinical trials (RCTs) 19,[21][22][23][24][25][26][27] have yielded inconsistent results. Accordingly, there is uncertainty about whether patients on dialysis should be treated with nutritional vitamin D in addition to VDRAs.…”

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confidence: 99%

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Ergocalciferol Supplementation in Hemodialysis Patients With Vitamin D Deficiency: A Randomized Clinical Trial

Miskulin

Majchrzak²,

Tighiouart

et al. 2015

JASN

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Locally produced 1,25-dihydroxyvitamin D3 may have pleiotropic effects outside of bone. Experimental and observational studies suggest that nutritional vitamin D may enhance erythropoiesis in settings of 25-hydroxy vitamin D (25(OH)D) deficiency. We conducted a double-blind, placebo-controlled, randomized clinical trial to assess the effects of supplementation with ergocalciferol on epoetin utilization and other secondary outcomes in patients on hemodialysis with serum 25(OH)D ,30 ng/ml. In all, 276 patients were randomized to 6 months of ergocalciferol or placebo. Mean6SD serum 25(OH)D increased from 16.065.9 ng/ml at baseline to 39.2614.9 ng/ml in the ergocalciferol arm and did not change (16.966.4 ng/ml and 17.567.4 ng/ml, respectively) in the placebo arm. There was no significant change in epoetin dose over 6 months in the ergocalciferol or placebo arms (geometric mean rate 0.98 [95% confidence interval (95% CI), 0.94 to 1.02] versus 0.99 [95% CI, 0.95 to 1.03], respectively) and no difference across arms (P=0.78). No change occurred in serum calcium, phosphorus, intact parathyroid hormone, or C-reactive protein levels, cinacalcet use, or phosphate binder or calcitriol dose in either study arm. Rates of all-cause, cardiovascular, and infection-related hospitalizations did not differ by study arm, although statistical power was limited for these outcomes. In conclusion, 6 months of supplementation with ergocalciferol increased serum 25(OH)D levels in patients on hemodialysis with vitamin D insufficiency or deficiency, but had no effect on epoetin utilization or secondary biochemical and clinical outcomes.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionsupporting

confidence: 82%

See 1 more Smart Citation

Ergocalciferol Supplementation in Hemodialysis Patients With Vitamin D Deficiency: A Randomized Clinical Trial

Miskulin

Majchrzak²,

Tighiouart

et al. 2015

JASN

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“…Wasse et al 23 have used a very high dose of 200,000 IU/week of cholecalciferol for 3 weeks and indicated that 90.5% of the subjects achieved serum 25(OH) D concentrations of≥30 ng/mL, whereas a pharmacokinetic analysis revealed that 10,333 IU/week of cholecalciferol produced a steady state of 24 ng/mL of 25(OH) D with no apparent toxicities 22. The Kidney Diseases Outcomes Quality Initiative (KDOQI) guidelines recommend 50,000 IU/month to 50,000 IU/week of vitamin D 2 which effectively increase 25(OH) D levels 19. Estimates of the vitamin D supplement required by patients on dialysis to give 25-OH-D levels >30 ng/mL are between 1800 and 5000 IU/day,33 which is within the range used in the studies included in the current review.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Responses to Vitamin D3 (Cholecalciferol) in Patients on Dialysis: A Systematic Review and Meta-Analysis

Chen

Zhao

et al. 2016

Journal of Investigative Medicine

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Vitamin D plays a key role in mineral metabolism and its deficiency is often noted in patients on dialysis for end-stage renal disease (ESRD). We evaluated the efficacy and responses to vitamin D3 (cholecalciferol) in patients undergoing dialysis for ESRD. Randomized controlled trials or prospective studies comparing vitamin D3 supplementation to placebo in patients with ESRD on dialysis were searched from medical databases using the terms, 'Calcitriol/Cholecalciferol, vitamin D, chronic kidney disease, hemodialysis, serum calcium, parathyroid hormones (PTH), phosphorus, 25(OH)D, and 1,25(OH)2D'. The outcomes analyzed were serum calcium, PTH, phosphorus, 25(OH)D, and 1,25(OH) 2D levels. Of the 259 records identified, 9 studies with a total of 368 patients were chosen for the current meta-analysis. The number of patients, age, and gender distribution among the groups were comparable. Results reveal a greater increase in both 25(OH)D (Pooled difference in means=0.434, 95% CI 0.174 to 0.694, p=0.001) and 1,25(OH) 2D (Pooled difference in means=0.978, 95% CI 0.615 to 1.34, p<0.001) in the treatment arm, as compared to the placebo. There was no difference in the serum calcium or PTH among the two groups. However, patients in the treatment arm had a significant increase in phosphorus levels (Pooled difference in means=0.434, 95% CI 0.174 to 0.694, p=0.001). Vitamin D supplementation facilitated the maintenance of increased levels of 25(OH) D and 1,25(OH) 2D in patients undergoing dialysis for ESRD. This increase in vitamin D was not associated with hypercalcemia or significant changes in PTH levels.

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“…Available data regarding the effects of vitamin D supplementation on the VC risk markers fetuin-A and dpucMGP are scarce: In hemodialysis patients, administration of the vitamin D analog paricalcitol for 8 weeks was associated with an increase in fetuin-A concentrations, but no control group without paricalcitol administration was available [22]. Weekly supplementation with 25,000 IU vitamin D for 13 weeks also increased fetuin-A concentrations in an RCT in hemodialysis patients [23].…”

Section: Discussionmentioning

confidence: 99%

Daily Supplementation with 4000 IU Vitamin D3 for Three Years Does Not Modify Cardiovascular Risk Markers in Patients with Advanced Heart Failure: The Effect of Vitamin D on Mortality in Heart Failure Trial

Zittermann¹,

Ernst²,

Prokop³

et al. 2018

Ann Nutr Metab

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Background/Aims: We aimed to investigate the effect of a moderately high vitamin D dose on lipid parameters and biochemical markers of vascular calcification (VC) in patients with established cardiovascular disease. Methods: We included in this pre-specified secondary analysis of a randomized controlled trial 161 patients with advanced heart failure and 25-hydroxyvitamin D (25OHD) concentrations < 75 nmol/L (vitamin D group: n = 80; placebo group: n = 81), who received a daily vitamin D₃ supplement of 4,000 IU for 3 years. We assessed between-group differences of the lipid parameters total-cholesterol, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol, and triglycerides, and the VC markers fetuin-A and non-phosphorylated undercarboxylated matrix gla protein (MGP) at study termination, with adjustment for baseline values. Results: Lipid parameters, the percentage of patients with dyslipoproteinemia, and VC markers did not differ significantly between groups at study termination (p values: 0.395–0.939). Likewise, vitamin D achieved no significant treatment effect on these markers in subgroup analyses in patients with 25OHD concentrations < 30 nmol/L, nonusers of lipid-lowering drugs, or diabetic patients (p values: 0.245–0.998). Conclusion: Our data indicate that vitamin D does not improve the lipid profile and does not influence the calcification inhibitors fetuin-A and non-phosphorylated undercarboxylated MGP in patients with advanced heart failure.

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Biochemical Parameters After Cholecalciferol Repletion in Hemodialysis: Results From the VitaDial Randomized Trial

Cited by 59 publications

References 39 publications

Ergocalciferol Supplementation in Hemodialysis Patients With Vitamin D Deficiency: A Randomized Clinical Trial

Ergocalciferol Supplementation in Hemodialysis Patients With Vitamin D Deficiency: A Randomized Clinical Trial

Evaluation of Responses to Vitamin D3 (Cholecalciferol) in Patients on Dialysis: A Systematic Review and Meta-Analysis

Daily Supplementation with 4000 IU Vitamin D3 for Three Years Does Not Modify Cardiovascular Risk Markers in Patients with Advanced Heart Failure: The Effect of Vitamin D on Mortality in Heart Failure Trial

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