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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002532
Receipt No. R000003094
Scientific Title Double blinded randomized placebo controlled trial to examine if intake of vitamin D supplement can prevent INFLUENZA PANDEMIC (H1N1) 2009 targeting on high school students
Date of disclosure of the study information 2009/10/17
Last modified on 2009/12/21

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Basic information
Public title Double blinded randomized placebo controlled trial to examine if intake of vitamin D supplement can prevent INFLUENZA PANDEMIC (H1N1) 2009 targeting on high school students
Acronym Amateras IX
Scientific Title Double blinded randomized placebo controlled trial to examine if intake of vitamin D supplement can prevent INFLUENZA PANDEMIC (H1N1) 2009 targeting on high school students
Scientific Title:Acronym Amateras IX
Region
Japan

Condition
Condition Influenza Pandemic (H1N1) 2009 Virus
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will determine if vitamin D3 peroral administration of 2000IU/day for 9 weeks can prevent incidence of INFLUENZA PANDEMIC (H1N1) 2009 diagnosed by medical doctors, and upper and lower respiratory symptoms, by conducting a double blind randomized controlled clinical trial and by targeting high school students.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes doctor diagnosed influenza A
Key secondary outcomes upper and lower respiratory symptoms
School absent days

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
Food
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
15 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria 1. Both the subject and guardian agreed to participate in the trial with written form of consent
2. Nothing correspond to excluding criteria
Key exclusion criteria 1. Person who was already infected with Influenza Pandemic (H1N1) 2009 Virus
2. Person who has past history of urinary tract stone
3. Person who has chronic disease and taking any medication for more than one month
4. Person who is taking vitamin D supplement
5. Person who has serious allergy
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 Molecular Epidemiology
Zip code
Address 3-25-8 Nishi-shimbashi, Minato-ku, Tokyo, 1058461 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 Molecular Epidemiology
Zip code
Address
TEL
Homepage URL
Email emisuzu@jikei.ac.jp

Sponsor
Institute Jikei University School of Medicine
Division of Molecular Epidemiology
Institute
Department

Funding Source
Organization Jikei University School of Medicine
Division of Molecular Epidemiology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Seisoku High School
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
2009 Year 10 Month 17 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
2009 Year 09 Month 18 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
2009 Year 12 Month 01 Day
Date trial data considered complete
2009 Year 12 Month 01 Day
Date analysis concluded
2010 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 09 Month 19 Day
Last modified on
2009 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003094

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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