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Recruitment status Completed
Unique ID issued by UMIN UMIN000001373
Receipt No. R000001667
Scientific Title A Randomized, Double Blind, Comparative Study Of STATUS D3Ⓡ (vitamin D3) Versus Placebo In Children Aged Between 7 And 15 Years Old to prevent infectious diseases including influenza and to improve atopic dermatitis
Date of disclosure of the study information 2008/10/01
Last modified on 2009/06/27

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Basic information
Public title A Randomized, Double Blind, Comparative Study Of STATUS D3Ⓡ (vitamin D3) Versus Placebo In Children Aged Between 7 And 15 Years Old to prevent infectious diseases including influenza and to improve atopic dermatitis
Acronym Preventive Effects of Vitamin D on Infectious Diseases and Allergic conditions Trials for Children Study: PEDIATRICS
Scientific Title A Randomized, Double Blind, Comparative Study Of STATUS D3Ⓡ (vitamin D3) Versus Placebo In Children Aged Between 7 And 15 Years Old to prevent infectious diseases including influenza and to improve atopic dermatitis
Scientific Title:Acronym Preventive Effects of Vitamin D on Infectious Diseases and Allergic conditions Trials for Children Study: PEDIATRICS
Region
Japan

Condition
Condition elementary shool, junior high school children
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Between 2008 Dec 1 and 2009 Mar 31, we will determine if vitamin D3 peroral administration can reduce the risk of doctor-diagnosed influenza as well as gastric enteritis, febrile diseases, admission to hospital, absent days from school, changes of child behavior check list and improvement of atopic dermatitis, by conducting a double blind randomized controlled clinical trial and by targeting age 7 to 15 years old.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes doctor-diagnosed influenza
Key secondary outcomes gastric enteritis, febrile diseases, admission to hospital, absent days from school, changes of child behavior check list and improvement of atopic dermatitis

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 Prevention
Type of intervention
Medicine
Interventions/Control_1 vitamin D3
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
6 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria Elementary school and junior high school children
Obtaining written formed informed consent
Key exclusion criteria 1. already taking vitamin D3 or active form of vitamin D
2. past history of urethral stone, or having underlying diseases related with calcium and/or bone metabolism
3. known allergy to sesame, gelatin, d-solvitor,
4. difficulty in swallowing capsules for 4 months
5. during or within 1 year after chemotherapy or immunocompromised conditions
6. known to move during study period
7. other reasons that doctor judges impossible to attend the study
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuyoshi Urashima
Organization Jikei University School of Medicine
Division name Division of Clinical Research and Development
Zip code
Address 3-25-8, Nishi-shimbashi, Minato-ku, Tokyo, JAPAN
TEL 03-3433-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Emi Suzuki
Organization Jikei University School of Medicine
Division name Division of Clinical Research and Development
Zip code
Address 3-25-8, Nishi-shimbashi, Minato-ku, Tokyo, JAPAN
TEL 03-3433-1111
Homepage URL http://docrd.jp
Email urashima@jikei.ac.jp

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)

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
2008 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 Completed
Date of protocol fixation
2008 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 06 Month 01 Day
Date trial data considered complete
2009 Year 06 Month 01 Day
Date analysis concluded
2009 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 09 Month 13 Day
Last modified on
2009 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001667


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