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ISRCTN
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ISRCTN84437785
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DOI
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10.1186/ISRCTN84437785
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Calcium supplementation and weight-bearing physical activity: do they have a combined effect on the bone mineral density of pre-pubertal children?
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Scientific title
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A double blind, randomised controlled trial of the effects of calcium supplementation on bone density, geometry and strength in pre-pubertal gymnasts and healthy controls
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Acronym
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N/A
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Serial number at source
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AP0782
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Study hypothesis
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To investigate whether there is a differential response to calcium supplementation in elite gymnasts and school children controls.
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Lay summary
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Ethics approval
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Added 25/01/2010:
1. Central Manchester Research Ethics Committee approved on the 1st August 2000 (ref: CEN/00/44). South Manchester Ethics Board also gave approval on the 1st February 2001 under reciprocal arrangements with Central Manchester Research Ethics Committee which used to be in place in Manchester.
2. Stockport Research Ethics Committee approved on the 3rd July 2000 (ref: Min No 1875)
3. Liverpool Children’s Research Ethics Committee approved on the 3rd January 2002 (ref: 01/27/E)
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Calcium supplementation and bone mineral density
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Participants - inclusion criteria
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1. Pre-pubertal children aged 5 - 14 years, either sex
2. Signed parental or guardian consent received
3. Agreement to participate by the child
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/01/2002
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Anticipated end date
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01/01/2006
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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86
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Interventions
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Gymnasts who participate in greater than 6 hours high intensity gymnastics a week. Sedentary children who participate in less than 2 hours high intensity weight bearing exercise per week.
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Primary outcome measure(s)
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Increase in cortical and trabecular volumetric bone mineral density (vBMD) at the radius and tibia, assessed using peripheral quantitative computed tomography (pQCT).
Added 25/01/2010:
All outcomes were measured at baseline and 12 months after completing 12 months supplementation.
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Secondary outcome measure(s)
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Changes in:
1. Bone geometry at the radius and tibia
2. Lumbar spine
3. Whole body measurements
Assessed using peripheral quantitative computed tomography (pQCT) (distal and diaphyseal radius and tibia) and dual energy X-ray absorptiometry (DXA) (lumbar spine and whole body).
Added 25/01/2010:
All outcomes were measured at baseline and 12 months after completing 12 months supplementation.
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Sources of funding
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Action Medical Research (UK)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17870038
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Contact name
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Dr
MZ
Mughal
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Address
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Saint Mary's Hospital
Hathersage Road
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City/town
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Manchester
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Zip/Postcode
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M13 0JH
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Country
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United Kingdom
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Tel
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+44 (0)161 276 6501
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Fax
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+44 (0)161 276 6907
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Email
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zulf.mughal@man.ac.uk
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Sponsor
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Action Medical Research (UK)
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Address
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Vincent House
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City/town
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Horsham West Sussex
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Zip/Postcode
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RH12 2DP
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Country
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United Kingdom
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Tel
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+44 (0)1403 210 406
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Fax
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+44 (0)1403 210 541
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Email
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info@actionresearch.co.uk
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Sponsor website:
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http://www.action.org.uk/
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Date applied
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01/03/2001
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Last edited
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25/01/2010
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Date ISRCTN assigned
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01/03/2001
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