UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001975 |
|---|---|
| Receipt number | 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 09:44:53 |
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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
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
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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002410
