UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000017834 |
| Receipt No. | R000020657 |
| Scientific Title | A prospective study investivating the relationship between vitamin B6 status and cytopenias in patients with hematological disorders. |
| Date of disclosure of the study information | 2015/06/24 |
| Last modified on | 2019/08/17 (Ver. 10) |
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| Basic information | ||
| Public title | A prospective study investivating the relationship between vitamin B6 status and cytopenias in patients with hematological disorders. | |
| Acronym | Vitamin B6 status and cytopenias in hematological disorders. | |
| Scientific Title | A prospective study investivating the relationship between vitamin B6 status and cytopenias in patients with hematological disorders. | |
| Scientific Title:Acronym | Vitamin B6 status and cytopenias in hematological disorders. | |
| Region |
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| Condition | ||
| Condition | hematological disorders | |
| Classification by specialty |
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| Classification by malignancy | Malignancy | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | The objective of this study is to assess vitamin B6 levels in patients with hematological disorders associated with cytopenias, and observe whether supplementation of vitamin B6 in deficient patients improves cytopenias. |
| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | hemoglobin and transfusion frequencies after administration of vitamin B6 |
| Key secondary outcomes | |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Single arm |
| Randomization | Non-randomized |
| Randomization unit | |
| Blinding | Open -no one is blinded |
| Control | Uncontrolled |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | ||
| No. of arms | 1 | |
| Purpose of intervention | Treatment | |
| Type of intervention |
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| Interventions/Control_1 | Intervention in patients with low vitamin B6 levels will begin with oral administration of 6 tablets of Pydoxal 10mg tablets (Pyridoxal Phosphate Hydrate) per day, and if vitamin B6 levels are not elevated at 6 weeks, treatment will be switched to either subcutaneous, intramuscular, or intravenous injections of Pydoxal. Injection frequencies and dose will be decided by the attending physician by monitoring vitamin B6 levels. Administration of vitamin B6 will continue from date of initiation to May 31, 2017. | |
| Interventions/Control_2 | ||
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| Interventions/Control_5 | ||
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| Interventions/Control_7 | ||
| Interventions/Control_8 | ||
| Interventions/Control_9 | ||
| Interventions/Control_10 | ||
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | patients over 20 years old with a hematological disorder associated with cytopenias | |||
| Key exclusion criteria | 1. patients with Parkinson's disease or Parikinson's syndrome
2. patients under treatment with levodopa |
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| Target sample size | 150 | |||
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| Name of lead principal investigator |
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| Organization | Juntendo University Hospital | ||||||
| Division name | Department of Hematology | ||||||
| Zip code | 113-0033 | ||||||
| Address | 3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan | ||||||
| TEL | 03-3813-3111 | ||||||
| hyasuda@juntendo.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Juntendo University Hospital | ||||||
| Division name | Department of Hematology | ||||||
| Zip code | 113-0033 | ||||||
| Address | 3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan | ||||||
| TEL | 03-3813-3111 | ||||||
| Homepage URL | |||||||
| hyasuda@juntendo.ac.jp | |||||||
| Sponsor | |
| Institute | Juntendo University Hospital |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Department of Hematology, Juntendo University Hospital |
| Organization | |
| Division | |
| Category of Funding Organization | Self funding |
| Nationality of Funding Organization | |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Juntendo University Hospital IRB |
| Address | 3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan |
| Tel | 03-5802-1584 |
| kenkyu5858@juntendo.ac.jp | |
| Secondary IDs | |
| Secondary IDs | NO |
| Study ID_1 | |
| Org. issuing International ID_1 | |
| Study ID_2 | |
| Org. issuing International ID_2 | |
| IND to MHLW | |
| Institutions | |
| Institutions | 順天堂大学医学部付属順天堂医院（東京都）/Juntendo University Hospital(Tokyo)
順天堂大学医学部付属浦安病院（千葉県）/Juntendo University Urayasu Hospital(Chiba) 順天堂大学医学部付属練馬病院（東京都）/Juntendo University Nerima Hospital(Tokyo) |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | www.springer.com/medicine/internal/journal/12185 |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | www.springer.com/medicine/internal/journal/12185 | ||||||
| Number of participants that the trial has enrolled | 23 | ||||||
| Results | 23 patients (12 primary myelofibrosis patients and 11 secondary myelofibrosis patients) were analyzed. A total of 16 out of 23 patients (69.6%) were found to have VB6 deficiency, but VB6 supplementation with pyridoxal phosphate hydrate did not improve hemoglobin levels in any of the patients. |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results | |||||||
| Baseline Characteristics | 23 patients (12 primary myelofibrosis patients and 11 secondary myelofibrosis patients) |
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| Participant flow | After written informed consent, patients were tested for vitamin B6 deficiency. In deficient patients, vitamin B6 was administered. |
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| Adverse events | 4 patients treated with vitamin B6 (pyridoxal phosphate hydrate) died to causes urelated to vitamin B6 administration. |
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| Outcome measures | hemoglobin levels |
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| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Management information | |||||||
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020657 |
