UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000027531