UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized, double blind, comparative study of vitamin D3 versus placebo in small children with asthma to prevent asthma attack
Title of the study (Brief title)	ATP XII
Region	Japan

Condition
Condition	asthma (2 - 5 years old)
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will determine if vitamin D3 peroral administration of 600IU/day for two months can prevent asthma attack in children (2 – 5 years old) with asthma not using steroid inhalation for the next 4 months, 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	frequency of asthma attack diagnosed by collaborating medical doctors
Key secondary outcomes	Improvement of IgE RIST, RAST, SCORAD, changes of ACT score reduce of drug usage

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	2 years-old <=
Age-upper limit	6 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. Drugs of steroid inhalation has not been used for. 3. 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	Mitsuyoshi Urashima
Organization	Jikei University School of Medicine
Division name	Molecular Epidemiology
Address	3-25-8 Nishi-shimbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Email

Public contact
Name of contact person	Mitsuyoshi Urashima
Organization	Jikei University School of Medicine
Division name	Molecular Epidemiology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 06 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 09 Month 05 Day
Last modified on	2016 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000004995