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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024033
Receipt No. 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

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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
Email 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
Email watabe@derma.med.tohoku.ac.jp

Sponsor
Institute Department of Dermatology
Graduate School of Medicine, Tohoku University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020439

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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