Effect of cholecalciferol on serum hepcidin and parameters of anaemia and CKD-MBD among haemodialysis patients: a randomized clinical trial

Abstract In this multicentre double-blind randomized clinical trial, we investigated the effects of oral cholecalciferol supplementation on serum hepcidin and parameters related to anaemia and CKD-MBD among haemodialysis patients. Participants were assigned in a 2:2:1:1 ratio to either (1) thrice-weekly 3,000-IU cholecalciferol, (2) once-monthly cholecalciferol (equivalent to 9,000 IU/week), (3) thrice-weekly placebo, or (4) once-monthly placebo. We also examined the effect modifications by selected single nucleotide polymorphisms in vitamin D-related genes. Out of 96 participants, 94 were available at Month 3, and 88 completed the 6-month study. After adjustment for baseline values, serum hepcidin levels were higher at Day 3 in the combined cholecalciferol (vs. placebo) group, but were lower at Month 6 with increased erythropoietin resistance. Cholecalciferol increased serum 1,25(OH)2D levels, resulting in a greater proportion of patients who reduced the dose of active vitamin D at Month 6 (31% vs. 10% in the placebo group). Cholecalciferol also suppressed intact PTH only among patients with severe vitamin D deficiency. In conclusion, cholecalciferol supplementation increases serum hepcidin-25 levels in the short term and may increase erythropoietin resistance in the long term among haemodialysis patients. Both thrice-weekly and once-monthly supplementation effectively increases serum 1,25(OH)2D levels, and hence, reduces active vitamin D drugs. Clinical Trial Registry: This study was registered at ClinicalTrials.gov and University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) as NCT02214563 (registration date: 12/08/2014) and UMIN000011786 (registration date: 15/08/2014), respectively (please refer to the links below). ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/record/NCT02214563. UMIN-CTR: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000017152&language=E.

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Vitamin D and Serum Cytokines in a Randomized Clinical Trial

International Journal of Endocrinology ◽

10.1155/2010/305054 ◽

2010 ◽

Vol 2010 ◽

pp. 1-7 ◽

Cited By ~ 34

Author(s):

Eleanor Yusupov ◽

Melissa Li-Ng ◽

Simcha Pollack ◽

James K. Yeh ◽

Mageda Mikhail ◽

...

Keyword(s):

Vitamin D ◽

Placebo Group ◽

Vitamin D3 ◽

Intracellular Signaling ◽

Final Visit ◽

Active Vitamin ◽

Gm Csf ◽

Active Vitamin D ◽

Significant Difference ◽

Vitamin D3 Supplementation

Background. The role of vitamin D in the body's ability to fight influenza and URI's may be dependent on regulation of specific cytokines that participate in the host inflammatory response. The aim of this study was to test the hypothesis that vitamin D can influence intracellular signaling to regulate the production of cytokines.Subjects and Methods. This study was a 3-month prospective placebo-controlled trial of vitamin D3 supplementation in ambulatory adults [Li-Ng et al., 2009]. 162 volunteers were randomized to receive either 50 μg/d(2000 IU) of vitamin D3 or matching placebo. 25(OH)D and the levels of 10 different cytokines (IL-2, 4, 5, 6, 8, 10, 13, GM-CSF, IFN-γ, TNF-α) were measured in the serum of participants at baseline and the final visit. There were 6 drop-outs from the active vitamin D group and 8 from the placebo group.Results. In the active vitamin D group, we found a significant median percent decline in levels of GM-CSF (−62.9%,P<.0001), IFN-γ(−38.9%,P<.0001), IL-4 (−50.8%,P=.001), IL-8 (−48.4%,P<.0001), and IL-10 (−70.4%,P<.0001). In the placebo group, there were significant declines for GM-CSF (−53.2%,P=.0007) and IFN-γ(−34.4%,P=.0011). For each cytokine, there was no significant difference in the rate of decline between the two groups. 25(OH)D levels increased in the active vitamin D group from a mean of64.3±25.4 nmol/L to88.5±23.2 nmol/L.Conclusions. The present study did not show that vitamin D3 supplementation changed circulating cytokine levels among healthy adults.

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