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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001975
Receipt No. R000002410
Scientific Title Double blinded randomized placebo controlled trial to examine if maternal intake of vitamin D supplement can prevent atopic diseases through breast feeding
Date of disclosure of the study information 2009/05/18
Last modified on 2013/05/16

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Basic information
Public title Double blinded randomized placebo controlled trial to examine if maternal intake of vitamin D supplement can prevent atopic diseases through breast feeding
Acronym Amaterasu 6
Scientific Title Double blinded randomized placebo controlled trial to examine if maternal intake of vitamin D supplement can prevent atopic diseases through breast feeding
Scientific Title:Acronym Amaterasu 6
Region
Japan

Condition
Condition Exanthema on face at one month of age
Breast feeding
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By per oral administration of vitamin D (or placebo) supplement for 6 weeks to mothers whose child at one month of age has exanthema on face, we aim to examine if atopic dermatitis scored with SCORAD can be improved and if occurrences of food allergy, bronchial asthma, and asthmatic bronchitis can be prevented by vitamin D compared with placebo.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes dermatitis estimated with SCORAD
Key secondary outcomes onset of food allergy
asthmatic bronchitis
bronchial asthma

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 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
2 weeks-old <=
Age-upper limit
6 weeks-old >=
Gender Male and Female
Key inclusion criteria 1) Exanthema on face at one month of age
2) Breast feeding
3) Obtained informed consent
Key exclusion criteria 1. Mother is already taking vitamin D3 supplement or active vitamin D
2. Mother has past history of urinary tract stone or underlying disease related with calcium or bone
3. Mother has allergy to food additives
4. Other difficulties judged by the surgeon in charge
Target sample size 130

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 105-8461 Japan
TEL
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

Sponsor
Institute Jikei University School of Medicine
Institute
Department

Funding Source
Organization Jikei University School of Medicine
Organization
Division
Category of Funding Organization
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
2009 Year 05 Month 18 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 02 Month 19 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 31 Day
Last follow-up date
2013 Year 01 Month 31 Day
Date of closure to data entry
2013 Year 02 Month 28 Day
Date trial data considered complete
2013 Year 03 Month 15 Day
Date analysis concluded
2013 Year 04 Month 15 Day

Other
Other related information

Management information
Registered date
2009 Year 05 Month 16 Day
Last modified on
2013 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002410

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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