UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024182 |
|---|---|
| Receipt number | 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 09:48:23 |
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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
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
mikaoga@kumamed.jp
Sponsor or person
Institute
National Hospital Organization Kumamoto Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027531
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
