Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
19/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M Z Mughal

ORCID ID

Contact details

SMH Central Manchester & Manchester Children's University Hospitals
St Mary's Hospital for Women & Children
Oxford Road
Manchester
M13 0JH
United Kingdom
+44 0161 276 6501
zulf.mughal@cmmc.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0453182967

Study information

Scientific title

Acronym

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

Not provided at time of registration

Study design

Pilot randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Vitamin D

Primary outcome measures

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 trial start date

12/06/2006

Overall trial end date

30/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Child

Gender

Female

Target number of participants

20 controls and 20 supplemented

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

United Kingdom

Trial participating centre

SMH Central Manchester & Manchester Children's University Hospitals
Manchester
M13 0JH
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20631020

Publication citations

  1. Results

    Ward KA, Das G, Roberts SA, Berry JL, Adams JE, Rawer R, Mughal MZ, A randomized, controlled trial of vitamin D supplementation upon musculoskeletal health in postmenarchal females., J. Clin. Endocrinol. Metab., 2010, 95, 10, 4643-4651, doi: 10.1210/jc.2009-2725.

Additional files

Editorial Notes