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Completed

NCT Number: NCT02214563

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

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

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Key information

Conditions

Kidney Failure, Chronic Anemia Avitaminosis Bone Diseases Bone Diseases, Metabolic Chronic Disease Deficiency Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Malnutrition Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vitamin D Deficiency

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hyogo Prefectural Nishinomiya Hospital, Nishinomiya, Hyōgo, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Dietary Supplement

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

Other names: vitamin D, vitamin D3

Olive Oil

Dietary Supplement

Primary outcomes

  1. Serum concentrations of hepcidin-25

    Time frame: The 3rd month

  2. Serum concentrations of hepcidin-25

    Time frame: The 3rd day

Secondary outcomes

  1. Serum concentrations of hepcidin-25

    Time frame: The 6th month

  2. Percent change of erythropoietin resistance index (ERI) overtime

    Time frame: Up to the 6th month

    ERI = Average weekly dose of erythropoiesis-stimulating agents (ESA) over prior 4 weeks / post-dialysis body weight (kg) / Hb (g/dL)

  3. Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b

    Time frame: The 3rd month

    In the secondary analysis, we will adjust baseline concentrations when comparing the groups.

  4. Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b

    Time frame: The 6th month

    In the secondary analysis, we will adjust baseline concentrations when comparing the groups.

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

    Time frame: The 3rd day

    In the secondary analysis, we will adjust baseline concentrations when comparing the groups.

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

    Time frame: The 3rd month

    In the secondary analysis, we will adjust baseline concentrations when comparing the groups.

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

    Time frame: The 6th month

    In the secondary analysis, we will adjust baseline concentrations when comparing the groups.

  8. Blood concentrations of calcium, phosphate, and intact parathyroid hormone overtime

    Time frame: Up to the 6th month

    In the secondary analysis, we will adjust baseline concentrations when comparing the groups.

Other outcomes

  1. Hypercalcemia

    Time frame: Up to the 6th month

    >=10.5 mg/dL of albumin corrected calcium

Sponsors and collaborators

Lead sponsor

Takayuki Hamano

Other

Collaborators

  • Akebono clinic
  • Futaba clinic
  • Higashikouri Hospital
  • Molecular Physiological Chemistry Laboratory, Inc.
  • Nishi clinic
  • Obi clinic
  • The Japan Kidney Foundation

Registry information

Official study title

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

Acronym: CHAMBER

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 12, 2014
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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