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 |
| Secondary identifying numbers | AP0782 |
- 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
Scientific
Saint Mary's Hospital
Hathersage Road
Manchester
M13 0JH
United Kingdom
| Phone | +44 (0)161 276 6501 |
|---|---|
| zulf.mughal@man.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/01/2002 |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Saint Mary's Hospital
Manchester
M13 0JH
United Kingdom
M13 0JH
United Kingdom
Sponsor information
Action Medical Research (UK)
Charity
Charity
Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom
| Website | http://www.action.org.uk/ |
|---|---|
"ROR" |
https://ror.org/01wcqa315 |
Funders
Funder type
Charity
Action Medical Research (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- actionmedres, action medical research for children, AMR
- Location
- United Kingdom
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 | 01/10/2007 | Yes | No |
