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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000024182
Date of registration:	27/09/2016
Prospective Registration:	No
Primary sponsor:	National Hospital Organization Kumamoto Medical Center
Public title:	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 - Effects of calcium supplementation on bone mineral density in milk allergy children
Date of first enrolment:	2016/07/01
Target sample size:	30
Recruitment status:	Complete: follow-up continuing
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027531
Study type:	Interventional
Study design:	Parallel Randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Mika Ogata
Address:	1-5 Ninomaru Chuo-ku Kumamoto-city 8600008 Japan
Telephone:	096-353-6501
Email:	mikaoga@kumamed.jp
Affiliation:	National Hospital Organization Kumamoto Medical Center Department of Pediatrics

Name:	Mika Ogata
Address:	1-5 Ninomaru Chuo-ku Kumamoto-city Japan
Telephone:	096-353-6501
Email:	mikaoga@kumamed.jp
Affiliation:	National Hospital Organization Kumamoto Medical Center Department of Pediatrics

Key inclusion & exclusion criteria

Inclusion criteria:
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

Age minimum: 8years-old
Age maximum: 15years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

cow's milk allergy

Intervention(s)

calcium 260 mg/day (as 2 g calcium lactate/day) for 12 months
calcium 260 mg/day(as 2 g calcium lactate/day) plus 1 alpha(OH)D3 0.25 microgram/day for 12 months

Primary Outcome(s)

bone mineral density

Secondary Outcome(s)

urinary calcium/creatinine ratio

Secondary ID(s)

Source(s) of Monetary Support

Japan Dairy Association Japan Milk Academic Alliance Dairy Products Health Science Council

Secondary Sponsor(s)

Jikei Hospital

Ethics review

Status: YES
Approval date:
Contact:

idera.kazuyuki.sg@mail.hosp.go.jp

National Hospital Organization Kumamoto Medical Center

0963536501

idera.kazuyuki.sg@mail.hosp.go.jp

Results

Results available:	Yes
Date Posted:
Date Completed:	31/03/2017
URL:

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