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 |
| Protocol serial number | N0453182967 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funders | Central Manchester and Manchester Children's University Hospitals NHS Trust (UK), NHS R&D Support Funding |
- 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 of protocol
Not provided at time of registration
Contact information
Dr M Z Mughal
Scientific
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 |
|---|---|
| zulf.mughal@cmmc.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot randomised controlled study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
The primary outcome measures for the study are the difference in bone mineral content and density over a 12 month period. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Female |
| Target sample size at registration | 40 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 12/06/2006 |
| Date of final enrolment | 30/08/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
SMH Central Manchester & Manchester Children's University Hospitals
Manchester
M13 0JH
United Kingdom
M13 0JH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
