UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017834 |
|---|---|
| Receipt number | 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 18:31:17 |
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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
| Japan |
Condition
Condition
hematological disorders
Classification by specialty
| Hematology and clinical oncology |
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
| Medicine |
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
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
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
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Yasuda |
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
| 1st name | Hajime |
| Middle name | |
| Last name | Yasuda |
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 or person
Institute
Juntendo University Hospital
Institute
Department
Personal name
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
| 2015 | Year | 06 | Month | 24 | Day |
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.
Results date posted
| 2019 | Year | 08 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
23 patients (12 primary myelofibrosis patients and 11 secondary myelofibrosis patients)
Participant flow
After written informed consent, patients were tested for vitamin B6 deficiency. In deficient patients, vitamin B6 was administered.
Adverse events
4 patients treated with vitamin B6 (pyridoxal phosphate hydrate) died to causes urelated to vitamin B6 administration.
Outcome measures
hemoglobin levels
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 29 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 29 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 07 | Day |
Last modified on
| 2019 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020657
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