Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients

Anemia Clinical Trial

— CHAMBER  

Official title:

Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER): A Multicenter, Double-blind, Randomized, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02214563
• Other study ID #: CKDR-003
• Status: Completed
• Phase: Phase 4
• Start date: August 2014
• Est. completion date: December 2016

Study information

• Verified date: August 2018
• Source: Osaka University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether cholecalciferol supplementation decrease the blood concentrations of hepcidin-25 in hemodialysis patients.

Description:

There are 4 arms in this study: (1) Thrice-weekly cholecalciferol supplementation (3,000 IU), (2) Monthly cholecalciferol supplementation (equivalent to 9,000/week), (3) Thrice-weekly placebo, and (4) Monthly placebo. The primary analyses will be done regarding 2 cholecalciferol groups and 2 placebo groups as one group each, and we will evaluate the effect of cholecalciferol regardless of the supplementation regimen. As the secondary analyses, we will examine if there is any difference between thrice-weekly and once-monthly supplementation regimen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients with end-stage renal disease receiving thrice-weekly maintenance hemodialysis

• On treatment with erythropoietin stimulating agent

• With written informed consent

Exclusion Criteria:

• On treatment with epoetin beta pegol as ESA

• On supplementation with native vitamin D

• Hypercalcemia (>=10.5 mg/dL of corrected serum calcium)

• On treatment with intravenous iron agents

• Judged as ineligible to the randomized study by the investigators

Related Conditions & MeSH terms

• Anemia
• Bone Diseases
• Bone Diseases, Metabolic
• Kidney Failure, Chronic
• Metabolic Diseases
• Renal Insufficiency
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Cholecalciferol
Made for this trial by Molecular Physiological Chemistry Laboratory, Inc.
• Olive oil

Locations

Country	Name	City	State
Japan	Higashikouri hospital	Hirakata	Osaka
Japan	Akebono clinic	Kumamoto
Japan	Hyogo Prefectural Nishinomiya Hospital	Nishinomiya	Hyogo
Japan	Futaba clinic	Osaka
Japan	Nishi clinic	Osaka
Japan	Obi clinic	Osaka
Japan	Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine	Suita	Osaka

Sponsors (8)

Lead Sponsor	Collaborator
Takayuki Hamano	Akebono clinic, Futaba clinic, Higashikouri Hospital, Molecular Physiological Chemistry Laboratory, Inc., Nishi clinic, Obi clinic, The Japan Kidney Foundation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hypercalcemia	>=10.5 mg/dL of albumin corrected calcium	Up to the 6th month
Primary	Serum concentrations of hepcidin-25		The 3rd month
Primary	Serum concentrations of hepcidin-25		The 3rd day
Secondary	Serum concentrations of hepcidin-25		The 6th month
Secondary	Percent change of erythropoietin resistance index (ERI) overtime	ERI = Average weekly dose of erythropoiesis-stimulating agents (ESA) over prior 4 weeks / post-dialysis body weight (kg) / Hb (g/dL)	Up to the 6th month
Secondary	Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b	In the secondary analysis, we will adjust baseline concentrations when comparing the groups.	The 3rd month
Secondary	Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b	In the secondary analysis, we will adjust baseline concentrations when comparing the groups.	The 6th month
Secondary	Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha	In the secondary analysis, we will adjust baseline concentrations when comparing the groups.	The 3rd day
Secondary	Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha	In the secondary analysis, we will adjust baseline concentrations when comparing the groups.	The 3rd month
Secondary	Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha	In the secondary analysis, we will adjust baseline concentrations when comparing the groups.	The 6th month
Secondary	Blood concentrations of calcium, phosphate, and intact parathyroid hormone overtime	In the secondary analysis, we will adjust baseline concentrations when comparing the groups.	Up to the 6th month

External Links

•   Link to the report which showed the negative effect of vitamin D on blood hepcidin-25 concentration in human subjects