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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004161
Receipt No. 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

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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 &#8211; 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
Email

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
Email

Sponsor
Institute Jikei University School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004996

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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