UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001373 |
|---|---|
| Receipt number | 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 09:56:16 |
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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
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
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
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
urashima@jikei.ac.jp
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001667
