Calcium supplementation and weight-bearing physical activity: do they have a combined effect on the bone mineral density of pre-pubertal children?

ISRCTN	ISRCTN84437785
DOI	https://doi.org/10.1186/ISRCTN84437785
Protocol serial number	AP0782
Sponsor	Action Medical Research (UK)
Funder	Action Medical Research (UK)

Submission date: 01/03/2001
Registration date: 01/03/2001
Last edited: 25/01/2010

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 of protocol

Not provided at time of registration

Contact information

Dr MZ Mughal
Scientific

Saint Mary's Hospital
Hathersage Road
Manchester
M13 0JH
United Kingdom

Phone	+44 (0)161 276 6501
Email	zulf.mughal@man.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	To investigate whether there is a differential response to calcium supplementation in elite gymnasts and school children controls.
Ethics approval(s)	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 Childrens Research Ethics Committee approved on the 3rd January 2002 (ref: 01/27/E)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/01/2006

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	5 Years
Upper age limit	14 Years
Sex	All
Target sample size at registration	86
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/01/2002
Date of final enrolment	01/01/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Saint Mary's Hospital

Manchester
M13 0JH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2007		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes