UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024033 |
|---|---|
| Receipt number | R000020439 |
| Scientific Title | Randomized trial of vitamin D supplementation (cholecalciferol) for vitiligo and rhodendrol-induced leucoderma patients. |
| Date of disclosure of the study information | 2016/09/13 |
| Last modified on | 2016/09/13 17:36:57 |
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Basic information
Public title
Randomized trial of vitamin D supplementation (cholecalciferol) for vitiligo and rhodendrol-induced leucoderma patients.
Acronym
Randomized trial of vitamin D supplementation (cholecalciferol) for vitiligo and rhodendrol-induced leucoderma patients.
Scientific Title
Randomized trial of vitamin D supplementation (cholecalciferol) for vitiligo and rhodendrol-induced leucoderma patients.
Scientific Title:Acronym
Randomized trial of vitamin D supplementation (cholecalciferol) for vitiligo and rhodendrol-induced leucoderma patients.
Region
| Japan |
Condition
Condition
vitiligo and rhodendrol-induced leucoderma.
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Clinical efficacy
Key secondary outcomes
serum 25(OH)D level
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Cholecalciferol oral administration 5000 IU/day
5 months
Interventions/Control_2
without intervention
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Vitiligo vulgaris and rhododendrol-induced leukoderma patients whose lesion has not changed for 6 months with other conservative treatments.
2. Patient with written informed consent for the treatment.
Key exclusion criteria
1. Patient under treatment with vitamin D3 ointments and/or phototherapy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiko Watabe |
Organization
Graduate School of Medicine, Tohoku University
Division name
Department of Dermatology
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, JAPAN
TEL
022-717-7271
watabe@derma.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Watabe |
Organization
Graduate School of Medicine, Tohoku University
Division name
Department of Dermatology
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, JAPAN
TEL
022-717-7271
Homepage URL
watabe@derma.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Dermatology
Graduate School of Medicine, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 13 | Day |
Last modified on
| 2016 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020439
