UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004159 |
|---|---|
| Receipt number | R000004994 |
| Scientific Title | A randomized, double blind, comparative study of vitamin D3 versus placebo in infant with atopy to prevent developing to asthma |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2015/09/05 14:08:16 |
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Basic information
Public title
A randomized, double blind, comparative study of vitamin D3 versus placebo in infant with atopy to prevent developing to asthma
Acronym
ATP XI
Scientific Title
A randomized, double blind, comparative study of vitamin D3 versus placebo in infant with atopy to prevent developing to asthma
Scientific Title:Acronym
ATP XI
Region
| Japan |
Condition
Condition
Atopic infants with IgE RAST + and more
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will determine if vitamin D3 peroral administration of 400IU/day can prevent developing to asthma in infants (0 -3 years old) with atopy (IgE RAST + and more), by conducting a double blind randomized controlled clinical trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
asthma diagnosed by collaborating medical doctors
Key secondary outcomes
Improvement of IgE RIST, RAST, SCORAD, reduce of drug usage
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
vitamin D3 supplement
Interventions/Control_2
placebo
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
| 0 | years-old | <= |
Age-upper limit
| 4 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Age 0 – 3 years old
IgE RIST positive (at least one item +) or eosinophil fraction 5% and more
Frequency of wheezing bronchitis is two and less in the past history
Infant who has not been diagnosed as bronchial asthma
In case of infant less than 1 year old, infant who is taking breast feeding dominantly.
Obtained informed consent
Key exclusion criteria
1. Already taking vitamin D supplement or 1,25 vitamin D
2. History of wheezy bronchitis 3 times and more, incubation and respiratory support during newborn period, addmitted due to RSV infection, urinary stone.
3. chronic disease including fracture, mental retardation, difficulty in swallowing.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuyoshi Urashima |
Organization
Jikei University School of Medicine
Division name
Molecular Epidemiology
Zip code
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuyoshi Urashima |
Organization
Jikei University School of Medicine
Division name
Molecular Epidemiology
Zip code
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jikei University School of Medicine
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
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
| 2010 | Year | 10 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 07 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | 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
| 2010 | Year | 09 | Month | 05 | Day |
Last modified on
| 2015 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004994
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
