Funded in part by Kissei, Japanese Association of Dialysis Physicians, Chugai Pharmaceutical, Kyowa Hakko Kirin, Inc., Chugai Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., Ltd., Molecular Physiological Chemistry Laboratory, Inc.
Effect of cholecalciferol on serum hepcidin and parameters of anaemia and CKD-MBD among haemodialysis patients: a randomized clinical trial
Obi Y, Yamaguchi S, Hamano T, Sakaguchi Y, Shimomura A, Namba-Hamano T, Mikami S, Nishi O, Tanaka M, Kamoto A, Obi Y, Tomosugi N, Tsubakihara Y, Isaka Y
Scientific reports · 5 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Industry funded
- Company
- Kissei
- Industry group
- Japanese Association of Dialysis Physicians
- Nonprofit
- Kidney Foundation, Japan
- Company
- Chugai Pharmaceutical
- Industry group
- The Japanese Association of Dialysis Physicians
- Company
- Kyowa Hakko Kirin, Inc.
- Nonprofit
- The Kidney Foundation, Japan
- Company
- Chugai Pharmaceutical Co., Ltd.
- Company
- Kissei Pharmaceutical Co., Ltd.
- Company
- Molecular Physiological Chemistry Laboratory, Inc.
- Grants
- Japanese Association of Dialysis Physicians (JADP Grant 2015-2); Kidney Foundation, Japan (JKFB 14-35)
Based on 10 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2020-09-23 · Sci Rep · vol. 10 · issue 1 · p. 15500
- Publisher
- Nature Portfolio
- Cited
- 10 citations · more than 77% of similar papers · 0.9× the field average
- References
- 42 works
- Access
- Open access (journal) · CC-BY
- Research areas
- Iron Metabolism and Disorders · Erythropoietin and Anemia Treatment · Pharmacological Effects and Toxicity Studies
- Keywords
- Cholecalciferol, Medicine, Placebo, Vitamin D and neurology, Internal medicine, Hepcidin, Gastroenterology, Vitamin, vitamin D deficiency, Clinical trial, Randomized controlled trial, Endocrinology, Anemia, Pathology
- MeSH
- humans, anemia, cholecalciferol, vitamin d, renal dialysis, drug administration schedule, double-blind method, polymorphism, single nucleotide, aged, middle aged, female, male, hepcidins, chronic kidney disease-mineral and bone disorder
14 authors
From US, JP
- Yoshitsugu ObiUniversity of Tennessee Health Science Center; The University of Osaka
- Satoshi YamaguchiThe University of Osaka
- Takayuki Hamano · correspondingNagoya City University; The University of Osaka
- Yusuke SakaguchiThe University of Osaka
- Akihiro ShimomuraThe University of Osaka
- Tomoko Namba‐HamanoThe University of Osaka
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 .
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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