Condition category
Nutritional, Metabolic, Endocrine
Date applied
01/03/2001
Date assigned
01/03/2001
Last edited
25/01/2010
Prospective/Retrospective
Prospectively 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 MZ Mughal

ORCID ID

Contact details

Saint Mary's Hospital
Hathersage Road
Manchester
M13 0JH
United Kingdom
+44 (0)161 276 6501
zulf.mughal@man.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AP0782

Study information

Scientific title

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

Acronym

Study hypothesis

To investigate whether there is a differential response to calcium supplementation in elite gymnasts and school children controls.

Ethics approval

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)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Calcium supplementation and bone mineral density

Intervention

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.

Intervention type

Supplement

Phase

Not Applicable

Drug names

Calcium supplementation

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/01/2002

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

86

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/01/2002

Recruitment end date

01/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Saint Mary's Hospital
Manchester
M13 0JH
United Kingdom

Sponsor information

Organisation

Action Medical Research (UK)

Sponsor details

Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom

Sponsor type

Charity

Website

http://www.action.org.uk/

Funders

Funder type

Charity

Funder name

Action Medical Research (UK)

Alternative name(s)

AMR

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17870038

Publication citations

  1. Results

    Ward KA, Roberts SA, Adams JE, Lanham-New S, Mughal MZ, Calcium supplementation and weight bearing physical activity--do they have a combined effect on the bone density of pre-pubertal children?, Bone, 2007, 41, 4, 496-504, doi: 10.1016/j.bone.2007.06.007.

Additional files

Editorial Notes