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Main
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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. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN84437785 |
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Date of registration:
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01/03/2001 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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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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Date of first enrolment:
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01/01/2002 |
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Target sample size:
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86 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN84437785 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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MZ
Mughal |
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Address:
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Saint Mary's Hospital
Hathersage Road
M13 0JH
Manchester
United Kingdom |
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Telephone:
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+44 (0)161 276 6501 |
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Email:
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zulf.mughal@man.ac.uk |
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Affiliation:
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Name:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Pre-pubertal children aged 5 - 14 years, either sex
2. Signed parental or guardian consent received
3. Agreement to participate by the child
Exclusion criteria: Does not meet inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Calcium supplementation and bone mineral density
Nutritional, Metabolic, Endocrine
Calcium supplementation
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Intervention(s)
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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(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(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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Source(s) of Monetary Support
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Action Medical Research (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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