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

Takayuki Hamano90 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Kidney Failure, Chronic Anemia Vitamin D Deficiency Bone Diseases, Metabolic

Interventions

CholecalciferolDIETARY_SUPPLEMENT

Made for this trial by Molecular Physiological Chemistry Laboratory, Inc.

Olive oilDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (7)

Hyogo Prefectural Nishinomiya Hospital

Nishinomiya, Hyōgo, Japan

Higashikouri hospital

Hirakata, Osaka, Japan

Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine

Suita, Osaka, Japan

Akebono clinic

Kumamoto, Japan

Outcomes

Primary Outcomes

Serum concentrations of hepcidin-25

Time frame: The 3rd month

Serum concentrations of hepcidin-25

Time frame: The 3rd day

Secondary Outcomes

Serum concentrations of hepcidin-25

Time frame: The 6th month

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)

Time frame: Up to the 6th month

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.

Time frame: The 3rd month

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.

Time frame: The 6th month

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.

Time frame: The 3rd day

Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha

Data from ClinicalTrials.gov

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