UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004161 |
|---|---|
| Receipt number | R000004996 |
| Scientific Title | A randomized, double blind, comparative study of vitamin D3 versus placebo in school children with asthma to prevent asthma attack |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2016/03/05 12:21:47 |
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Basic information
Public title
A randomized, double blind, comparative study of vitamin D3 versus placebo in school children with asthma to prevent asthma attack
Acronym
ATP XIII
Scientific Title
A randomized, double blind, comparative study of vitamin D3 versus placebo in school children with asthma to prevent asthma attack
Scientific Title:Acronym
ATP XIII
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will determine if vitamin D3 peroral administration of 800IU/day for two months can prevent asthma attack in children (6 – 15 years old) for the next 4 months (total 6 months observation), 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
frequencies and severity of asthma attack diagnosed by collaborating doctors
Key secondary outcomes
Improvement of IgE RIST, RAST, SCORAD,
changes of ACT score
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
Treatment
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
| 6 | years-old | < |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Age 2 – 5 years old children who have been diagnosed as asthma by collaborating doctors.
2. Obtained informed consent
Key exclusion criteria
1. Not using vitamin D supplement or active vitamin D
2. Past history
incubation and respiratory treatment
admission due to RS virus infection
urinary stone
3. Chronic disease including fracture
mental retardation
swallowing disturbance
4. other difficulties judged by the charged doctor
Target sample size
400
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
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/26841365
Number of participants that the trial has enrolled
Results
BACKGROUND:
In our prior randomized trial on preventing influenza, asthma attacks as a secondary outcome occurred less often in the vitamin D group than the placebo group. We aimed to clarify whether low-dose, short-term vitamin D supplementation, in addition to standard treatments, improves control of childhood asthma.
METHODS:
We conducted a randomized, double-blind, placebo-controlled trial comparing vitamin D3 supplements (800 IU/day) with placebo for 2 months in schoolchildren with asthma. The primary outcomes were frequency and severity of asthma judging from changes of asthma control levels defined by the Global Initiative for Asthma (GINA) by collaborating doctors at 2 and 6 months.
RESULTS:
Japanese schoolchildren with asthma (n=89) were randomly assigned to receive vitamin D (n=54) or placebo (n=35). At 2 months, GINA asthma control was significantly more improved in the vitamin D group compared with the placebo group (P=0.015). Childhood asthma control test (CACT) scores, a secondary outcome, were also significantly (P=0.004) improved in the vitamin D group compared with the placebo group at 2 months, and differences remained significant (P=0.012) at 6 months. The proportion of patients with a peak expiratory flow rate <80% predicted was significantly less in the vitamin D group (8/54: 15%) than the placebo group (12/35: 34%) at 6 months (P=0.032).
CONCLUSIONS:
Low-dose, short-term vitamin D supplementation in addition to standard treatment may improve levels of asthma control in schoolchildren. This article is protected by copyright. All rights reserved.
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
Main results already published
Date of protocol fixation
| 2010 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 04 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 20 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 04 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 05 | Day |
Last modified on
| 2016 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004996
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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