A pilot randomised controlled trial to determine if vitamin D treatment will result in greater bone mass acquisition in pubertal girls

ISRCTN	ISRCTN72827849
DOI	https://doi.org/10.1186/ISRCTN72827849
Secondary identifying numbers	N0453182967

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 19/10/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr M Z Mughal
Scientific

SMH Central Manchester & Manchester Children's University Hospitals
St Mary's Hospital for Women & Children
Oxford Road
Manchester
M13 0JH
United Kingdom

Phone	+44 0161 276 6501
Email	zulf.mughal@cmmc.nhs.uk

Study information

Study design	Pilot randomised controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study hypothesis	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?
Ethics approval(s)	Not provided at time of registration
Condition	Nutritional, Metabolic, Endocrine: Supplements
Intervention	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.
Intervention type	Supplement
Primary outcome measure	The primary outcome measures for the study are the difference in bone mineral content and density over a 12 month period.
Secondary outcome measures	Not provided at time of registration
Overall study start date	12/06/2006
Overall study end date	30/08/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Female
Target number of participants	20 controls and 20 supplemented
Participant inclusion criteria	Not provided at time of registration
Participant exclusion criteria	Not provided at time of registration
Recruitment start date	12/06/2006
Recruitment end date	30/08/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

SMH Central Manchester & Manchester Children's University Hospitals

Manchester
M13 0JH
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Central Manchester and Manchester Children's University Hospitals NHS Trust (UK)

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2010		Yes	No