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ISRCTN
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ISRCTN72827849
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ClinicalTrials.gov identifier
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Public title
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A pilot randomised controlled trial to determine if vitamin D treatment will result in greater bone mass acquisition in pubertal girls
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0453182967
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Study hypothesis
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Does vitamin D status in young girls influence the accelerated bone growth that normally occurs around puberty and will supplementation with vitamin D to pubertal girls who have vitamin D deficiency lead to increased bone accrual in comparison to their placebo treated controls?
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Ethics approval
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Not provided at time of registration
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Study design
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Pilot randomised controlled study
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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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Nutritional, Metabolic, Endocrine: Supplements
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Participants - inclusion criteria
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Not provided at time of registration
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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12/06/2006
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Anticipated end date
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30/08/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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20 controls and 20 supplemented
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Interventions
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The DXA and pQCT scans will be analysed by Dr Ward and Professor Adams who will be ‘blinded’ as to the subject's study grouping. The primary muscle strength (JM force and power) and bone (TBBMC&D & radial BMC&D) outcome measures will be analysed after controlling for baseline measures, anthropometric variables, baseline 25(OH)D concentration, calcium intake and physical activity using appropriate analysis of covariance models. Descriptive and exploratory statistics will be used for the secondary outcomes, but these will be treated as exploratory. The correlation between Vitamin D status and serum ferritin concentrations will be determined using ANCOVA to adjust for treatment and other relevant variables.
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Primary outcome measure(s)
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The primary outcome measures for the study are the difference in bone mineral content and density over a 12 month period.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Central Manchester and Manchester Children's University Hospitals NHS Trust (UK)
NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Dr
M Z
Mughal
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Address
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SMH Central Manchester & Manchester Children's University Hospitals
St Mary's Hospital for Women & Children
Oxford 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 0161 276 6501
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Fax
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+44
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Email
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zulf.mughal@cmmc.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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28/09/2007
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Last edited
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28/05/2008
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Date ISRCTN assigned
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28/09/2007
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