Financiado en parte por 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 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- Kissei
- Grupo de la industria
- Japanese Association of Dialysis Physicians
- Organización sin fines de lucro
- Kidney Foundation, Japan
- Empresa
- Chugai Pharmaceutical
- Grupo de la industria
- The Japanese Association of Dialysis Physicians
- Empresa
- Kyowa Hakko Kirin, Inc.
- Organización sin fines de lucro
- The Kidney Foundation, Japan
- Empresa
- Chugai Pharmaceutical Co., Ltd.
- Empresa
- Kissei Pharmaceutical Co., Ltd.
- Empresa
- Molecular Physiological Chemistry Laboratory, Inc.
- Subvenciones
- Japanese Association of Dialysis Physicians (JADP Grant 2015-2); Kidney Foundation, Japan (JKFB 14-35)
Según 10 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2020-09-23 · Sci Rep · vol. 10 · número 1 · pág. 15500
- Editorial
- Nature Portfolio
- Citado
- 10 citas · más que el 77% de estudios similares · 0.9× el promedio de su campo
- Referencias
- 42 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Iron Metabolism and Disorders · Erythropoietin and Anemia Treatment · Pharmacological Effects and Toxicity Studies
- Palabras clave
- 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 autores
- Yoshitsugu Obi🇺🇸🇯🇵University of Tennessee Health Science Center; The University of Osaka
- Satoshi Yamaguchi🇯🇵The University of Osaka
- Takayuki Hamano🇯🇵 · autor de correspondenciaNagoya City University; The University of Osaka
- Yusuke Sakaguchi🇯🇵The University of Osaka
- Akihiro Shimomura🇯🇵The University of Osaka
- Tomoko Namba‐Hamano🇯🇵The University of Osaka
- Satoshi Mikami
- Osamu Nishi🇯🇵Osaka Nishi Clinic
- Motoko Tanaka🇯🇵Akebono (Japan); Akebono Clinic
- Akihito Kamoto🇯🇵Futaba clinic
- Yasue Obi🇺🇸🇯🇵University of Tennessee Health Science Center; The University of Osaka
- Naohisa Tomosugi🇯🇵Kanazawa Medical University
- Yoshiharu Tsubakihara🇯🇵Graduate School of Health Care Sciences, Jikei Institute
- Yoshitaka Isaka🇯🇵The University of Osaka
Resumen
El texto original del estudio, en el idioma en que se publicó.
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 .
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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