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| Name | Class |
|---|---|
| The Japan Kidney Foundation | OTHER |
| Molecular Physiological Chemistry Laboratory, Inc. | OTHER |
| Obi clinic | UNKNOWN |
| Higashikouri Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Thrice-weekly placebo | Placebo Comparator | Olive oil coated by soft capsule made of gelatin and glycerin. |
|
| Monthly placebo | Placebo Comparator | Olive oil coated by soft capsule made of gelatin and glycerin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Dietary Supplement | Made for this trial by Molecular Physiological Chemistry Laboratory, Inc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentrations of hepcidin-25 | The 3rd month | |
| Serum concentrations of hepcidin-25 | The 3rd day |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentrations of hepcidin-25 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Hypercalcemia | >=10.5 mg/dL of albumin corrected calcium | Up to the 6th month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoshiharu Tsubakihara, MD, PhD | Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hyogo Prefectural Nishinomiya Hospital | Nishinomiya | Hyōgo | 662-0918 | Japan | ||
| Higashikouri hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32968158 | Derived | 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. |
| Label | URL |
|---|---|
| Link to the report which showed the negative effect of vitamin D on blood hepcidin-25 concentration in human subjects | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 7, 2021 | |
| Reset | Oct 4, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 7, 2021 | Oct 4, 2021 |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D000740 | Anemia |
| D014808 | Vitamin D Deficiency |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D014807 | Vitamin D |
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| UNKNOWN |
| Nishi clinic | UNKNOWN |
| Futaba clinic | UNKNOWN |
| Akebono clinic | UNKNOWN |
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|
| Olive oil | Dietary Supplement |
|
| 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. | 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. | 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. | 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. | 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. | 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. | Up to the 6th month |
| Hirakata |
| Osaka |
| 573-0075 |
| Japan |
| Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine | Suita | Osaka | 565-0871 | Japan |
| Akebono clinic | Kumamoto | 861-4112 | Japan |
| Obi clinic | Osaka | 543-0052 | Japan |
| Nishi clinic | Osaka | 552-0007 | Japan |
| Futaba clinic | Osaka | 559-0013 | Japan |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |