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Biochemical parameters after cholecalciferol repletion in hemodialysis: results From the VitaDial randomized trial
Annick Massart1, Frédéric Daniel Debelle2, Judith Racapé3
1Nephrology Department, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.
Insights
Weekly oral cholecalciferol effectively raised vitamin D levels in hemodialysis patients. This safe and inexpensive treatment improved 25(OH)D and 1,25(OH)2D levels, offering a manageable solution for chronic kidney disease patients.
Area of Science:
- Nephrology
- Endocrinology
- Nutritional Science
Background:
- The Kidney Disease: Improving Global Outcomes (KDIGO) guideline recommends correcting low 25-hydroxyvitamin D3 (25[OH]D) levels (<30 ng/mL) in hemodialysis patients.
- However, specific treatment protocols for achieving these levels are not provided by current guidelines.
- Vitamin D deficiency is common in patients with chronic kidney disease (CKD) and maintenance hemodialysis.
Purpose of the Study:
- To evaluate the efficacy and safety of weekly oral cholecalciferol in correcting 25(OH)D deficiency in maintenance hemodialysis patients.
- To assess the impact of cholecalciferol treatment on secondary outcomes, including calcium, phosphorus, and intact parathyroid hormone (iPTH) levels.
- To determine the optimal dosage and duration for vitamin D repletion in this patient population.
Main Methods:
- A 2-center, double-blind, randomized controlled trial involving 55 adult maintenance hemodialysis patients with baseline 25(OH)D levels <30 ng/mL.
- Participants received either 25,000 IU of oral cholecalciferol weekly or a placebo for 13 weeks, followed by a 26-week open-label phase with individualized cholecalciferol dosing.
- Key measurements included serum 25(OH)D, 1,25-dihydroxyvitamin D3 (1,25[OH]2D), calcium, phosphorus, iPTH, and bone turnover markers.
Main Results:
- The primary endpoint, achieving 25(OH)D levels ≥30 ng/mL at 13 weeks, was significantly higher in the cholecalciferol group (61.5%) compared to placebo (7.4%; P<0.001).
- Cholecalciferol treatment also led to significant increases in 1,25(OH)2D levels and the proportion of patients achieving target calcium levels.
- Incidence of hypercalcemia, along with phosphate and iPTH levels, remained similar between groups, indicating a favorable safety profile.
Conclusions:
- Weekly oral administration of 25,000 IU of cholecalciferol for 13 weeks is an effective, safe, inexpensive, and manageable strategy to replete 25(OH)D and 1,25(OH)2D levels in hemodialysis patients.
- The study suggests that this regimen can help normalize vitamin D status in CKD patients on maintenance hemodialysis.
- Further research is recommended to evaluate the long-term clinical outcomes associated with this treatment approach.
Background:
The 2009 KDIGO (Kidney Disease: Improving Global Outcomes) chronic kidney disease-mineral and bone disorder clinical practice guideline suggests correcting 25-hydroxyvitamin D3 (25[OH]D) levels<30ng/mL in patients treated with maintenance hemodialysis, but does not provide a specific treatment protocol.
Study Design:
2-center, double-blind, randomized, 13-week, controlled trial followed by a 26-week open-label study.
Setting & Participants:
55 adult maintenance hemodialysis patients with 25(OH)D levels<30ng/mL were recruited from June 2008 through October 2009.
Intervention:
Cholecalciferol, 25,000IU, per week orally versus placebo for 13 weeks, then 26 weeks of individualized cholecalciferol prescription based on NKF-KDOQI (National Kidney Foundation-Kidney Disease Outcomes Quality Initiative) guidelines.
Outcomes:
Primary end point was the percentage of patients with 25(OH)D levels≥30ng/mL at 13 weeks. Secondary outcomes included the percentage of patients with normal calcium, phosphorus, and intact parathyroid hormone (iPTH) blood levels. Safety measures included incidence of hypercalcemia and hypervitaminosis D.
Measurements:
Blood calcium and phosphate were measured weekly; iPTH, 25(OH)D, 1,25-dihydroxyvitamin D3 (1,25[OH]2D), and bone turnover markers, trimonthly; fetuin A and fibroblast growth factor 23 (FGF-23) serum levels and aortic calcification scores were determined at weeks 0 and 39.
Results:
The primary end point significantly increased in the treatment group compared with the placebo group (61.5% vs 7.4%; P<0.001), as well as 1,25(OH)2D levels (22.5 [IQR, 15-26] vs 11 [IQR, 10-15]pg/mL; P<0.001) and the proportion of patients achieving the target calcium level (76.9% vs 48.2%; P=0.03). Incidence of hypercalcemia and phosphate and iPTH levels were similar between groups. The second 26-week study phase did not significantly modify the prevalence of 25(OH)D level≥30ng/mL in patients issued from the placebo group.
Limitations:
Small size of the study population.
Conclusions:
Oral weekly administration of 25,000IU of cholecalciferol for 13 weeks is an effective, safe, inexpensive, and manageable way to increase 25(OH)D and 1,25(OH)2D levels in hemodialysis patients. Further evaluation of clinical end points is suggested.
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