| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN72827849 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0453182967 |
| Public title | A pilot randomised controlled trial to determine if vitamin D treatment will result in greater bone mass acquisition in pubertal girls |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Nutritional, Metabolic, Endocrine: Supplements |
| 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? |
| Design/methodology | Pilot randomised controlled study |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Not provided at time of registration |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 12/06/2006 |
| Anticipated end date | 30/08/2007 |
| Status of trial | Completed |
| Target number of participants | 20 controls and 20 supplemented |
| Interventions | 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. |
| 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. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Central Manchester and Manchester Children's University Hospitals NHS Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr M Z Mughal |
| Contact details | SMH Central Manchester & Manchester Children's University Hospitals
St Mary's Hospital for Women & Children
Oxford Road
Manchester
United Kingdom
M13 0JH |
| Contact telephone | +44 0161 276 6501 |
| Contact fax | +44 |
| Contact email | zulf.mughal@cmmc.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN72827849 |
| Date last extracted from ISRCTN register | 17/04/2008 |
