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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024182
Receipt No. R000027531
Scientific Title Effects of calcium supplementation on bone mineral density in milk allergy children
Date of disclosure of the study information 2016/09/27
Last modified on 2019/09/30

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Basic information
Public title Effects of calcium supplementation on bone mineral density in milk allergy children
Acronym Effects of calcium supplementation on bone mineral density in milk allergy children
Scientific Title Effects of calcium supplementation on bone mineral density in milk allergy children
Scientific Title:Acronym Effects of calcium supplementation on bone mineral density in milk allergy children
Region
Japan

Condition
Condition cow's milk allergy
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate bone mineral density in children with cow's milk allergy.
To assess the effects of calcium or calcium and vitamine D supplementation on bone mineral density, and safety of them.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes bone mineral density
Key secondary outcomes urinary calcium/creatinine ratio

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 calcium 260 mg/day (as 2 g calcium lactate/day) for 12 months
Interventions/Control_2 calcium 260 mg/day(as 2 g calcium lactate/day) plus 1 alpha(OH)D3 0.25 microgram/day for 12 months
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
8 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria IgE-mediated cow's milk allergy
Key exclusion criteria 1.has complication as follows
1)Steroid-induced osteoporosis
2)osteogenesis imperfecta
3)Precocious puberty
4)other disease affecting calcium metabolism
2.Has taken following medications effected to calcium absorption and elimination before dosing
3.taking digitalis(contraindicated drug)
4.Ineligible patients according to the investigator's judgment
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Mika
Middle name
Last name Ogata
Organization National Hospital Organization Kumamoto Medical Center
Division name Department of Pediatrics
Zip code 8600008
Address 1-5 Ninomaru Chuo-ku Kumamoto-city
TEL 096-353-6501
Email mikaoga@kumamed.jp

Public contact
Name of contact person
1st name Mika
Middle name
Last name Ogata
Organization National Hospital Organization Kumamoto Medical Center
Division name Department of Pediatrics
Zip code 8600008
Address 1-5 Ninomaru Chuo-ku Kumamoto-city
TEL 096-353-6501
Homepage URL
Email mikaoga@kumamed.jp

Sponsor
Institute National Hospital Organization Kumamoto Medical Center
Institute
Department

Funding Source
Organization Japan Dairy Association
Japan Milk Academic Alliance
Dairy Products Health Science Council
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Jikei Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Kumamoto Medical Center
Address 1-5 Ninomaru Chuo-ku Kumamoto-city
Tel 0963536501
Email idera.kazuyuki.sg@mail.hosp.go.jp

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 国立病院機構熊本医療センター小児科(熊本県)
医療法人聖粒会 慈恵病院小児科(熊本県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 27 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 No longer recruiting
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 27 Day
Last modified on
2019 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027531

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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