Kidney Failure, ChronicPhase 4CHAMBERNCT02214563
Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients
A Phase 4 study testing Cholecalciferol and Olive oil in people with Kidney Failure, Chronic and Anemia, run by Takayuki Hamano at 7 sites in Japan.
Trial summary
The purpose of this study is to determine whether cholecalciferol supplementation decrease the blood concentrations of hepcidin-25 in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Anemia, Vitamin D Deficiency
- What is being tested?
- Cholecalciferol and Olive oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 7 sitesJapan
- Study dates
- Aug 2014to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with end-stage renal disease receiving thrice-weekly maintenance hemodialysis
- On treatment with erythropoietin stimulating agent
- With written informed consent
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Higashikouri hospital
Hirakata, Osaka, 573-0075
Akebono clinic
Kumamoto, 861-4112
Hyogo Prefectural Nishinomiya Hospital
Nishinomiya, Hyōgo, 662-0918
Obi clinic
Osaka, 543-0052
Nishi clinic
Osaka, 552-0007
Futaba clinic
Osaka, 559-0013
Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
Suita, Osaka, 565-0871
About this study
Official title: Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER): A Multicenter, Double-blind, Randomized, Placebo-controlled Trial
The purpose of this study is to determine whether cholecalciferol supplementation decrease the blood concentrations of hepcidin-25 in hemodialysis patients.
Read the detailed 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.
- Being tested
- Cholecalciferol, Olive oil
- Keywords
- Vitamin D, Cholecalciferol, Hepcidins, Renal Dialysis
- Medical subject headings
- Kidney Failure, Chronic, Anemia, Vitamin D Deficiency, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDietary supplement
Also called vitamin D, vitamin D3
Made for this trial by Molecular Physiological Chemistry Laboratory, Inc.
Olive oilDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Thrice-weekly cholecalciferol | Active comparator | Capsule containing 3,000 IU of cholecalciferol will be given at the end of each hemodialysis session. Dissolved with olive oil and coated by soft capsule made of gelatin and glycerin. Receives: Dietary Supplement: Cholecalciferol |
| Monthly cholecalciferol | Active comparator | Capsules containing a dose equivalent to 9,000 IU/week will be given at the end of the first hemodialysis session in the 3rd week of each month. Dissolved with olive oil and coated by soft capsule made of gelatin and glycerin. Receives: Dietary Supplement: Cholecalciferol |
| Thrice-weekly placebo | Placebo comparator | Olive oil coated by soft capsule made of gelatin and glycerin. Receives: Dietary Supplement: Olive oil |
| Monthly placebo | Placebo comparator | Olive oil coated by soft capsule made of gelatin and glycerin. Receives: Dietary Supplement: Olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentrations of hepcidin-25
Measured: The 3rd month
Serum concentrations of hepcidin-25
Measured: The 3rd day
Secondary outcomes (8)
Serum concentrations of hepcidin-25
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The 3rd day
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.
Measured: The 3rd 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.
Measured: The 6th month
Blood concentrations of calcium, phosphate, and intact parathyroid hormone overtime
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
Measured: Up to the 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takayuki Hamano
- Sponsor type
- University, hospital or other
- Collaborators
- The Japan Kidney Foundation, Molecular Physiological Chemistry Laboratory, Inc., Obi clinic, Higashikouri Hospital, Nishi clinic, Futaba clinic, Akebono clinic
- Responsible party
- Sponsor-investigator, Takayuki Hamano, Osaka University
- Investigators
- Yoshiharu Tsubakihara, MD, PhD, Study chair, Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214563
- Sponsor's protocol ID
- CKDR-003
- Acronym
- CHAMBER
- Status last verified
- Aug 2018
- First submitted
- 10 Aug 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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. Effect of cholecalciferol on serum hepcidin and parameters of anaemia and CKD-MBD among haemodialysis patients: a randomized clinical trial. Sci Rep. 2020 Sep 23;10(1):15500. doi: 10.1038/s41598-020-72385-w.
PubMed 32968158
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER): A Multicenter, Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02214563
- Acronym / sponsor ID
- CHAMBER / CKDR-003
- Keywords
- Vitamin D, Cholecalciferol, Hepcidins, Renal Dialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Takayuki HamanoUniversity, hospital or other
- Collaborators
- The Japan Kidney Foundation, Molecular Physiological Chemistry Laboratory, Inc., Obi clinic, Higashikouri Hospital, Nishi clinic, Futaba clinic, Akebono clinic
- Study start
- Aug 2014 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether cholecalciferol supplementation decrease the blood concentrations of hepcidin-25 in hemodialysis patients.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Thrice-weekly cholecalciferol | Active comparator | Dietary Supplement: CholecalciferolCapsule containing 3,000 IU of cholecalciferol will be given at the end of each hemodialysis session. Dissolved with olive oil and coated by soft capsule made of gelatin and glycerin. |
| Monthly cholecalciferol | Active comparator | Dietary Supplement: CholecalciferolCapsules containing a dose equivalent to 9,000 IU/week will be given at the end of the first hemodialysis session in the 3rd week of each month. Dissolved with olive oil and coated by soft capsule made of gelatin and glycerin. |
| Thrice-weekly placebo | Placebo comparator | Dietary Supplement: Olive oilOlive oil coated by soft capsule made of gelatin and glycerin. |
| Monthly placebo | Placebo comparator | Dietary Supplement: Olive oilOlive oil coated by soft capsule made of gelatin and glycerin. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with end-stage renal disease receiving thrice-weekly maintenance hemodialysis
- On treatment with erythropoietin stimulating agent
- With written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholecalciferolAlso: vitamin D, vitamin D3Made for this trial by Molecular Physiological Chemistry Laboratory, Inc. | Dietary supplement | Monthly cholecalciferol, Thrice-weekly cholecalciferol |
| Olive oil | Dietary supplement | Monthly placebo, Thrice-weekly placebo |
Primary outcome
Serum concentrations of hepcidin-25
Time frame: The 3rd month
Serum concentrations of hepcidin-25
Time frame: The 3rd day
8 secondary outcomes
Serum concentrations of hepcidin-25
Time frame: The 6th month
Percent change of erythropoietin resistance index (ERI) overtime
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
Time frame: The 3rd month
Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b
Time frame: The 6th month
Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha
Time frame: The 3rd day
Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha
Time frame: The 3rd month
Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha
Time frame: The 6th month
Blood concentrations of calcium, phosphate, and intact parathyroid hormone overtime
Time frame: Up to the 6th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Derived from this study: PubMed 32968158Obi 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. Effect of cholecalciferol on serum hepcidin and parameters of anaemia and CKD-MBD among haemodialysis patients: a randomized clinical trial. Sci Rep. 2020 Sep 23;10(1):15500. doi: 10.1038/s41598-020-72385-w.
- Link to the report which showed the negative effect of vitamin D on blood hepcidin-25 concentration in human subjectsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshiharu Tsubakihara, MD, PhD study chair
Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cholecalciferol and Olive oil in people with Kidney Failure, Chronic and Anemia, run by Takayuki Hamano at 7 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentrations of hepcidin-25 (time frame: The 3rd month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02214563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.