Combination therapy using calcium/vitamin D and protein/calorie supplements in nutritionally deficient women
| ISRCTN | ISRCTN62937696 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62937696 |
| Protocol serial number | AP0714 |
| Sponsor | Action Medical Research (UK) |
| Funder | Action Medical Research (UK) |
- Submission date
- 01/03/2001
- Registration date
- 01/03/2001
- Last edited
- 12/01/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Geeta Hampson
Scientific
Scientific
Senior Lecturer
Department of Chemical Pathology
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
| Phone | +44 (0)20 7928 9292 ext 2881 |
|---|---|
| geeta.hampson@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised controlled trial of combination therapy using calcium/vitamin D and protein/calorie supplements in nutritionally deficient women: an assessment of changes in osteoporotic fracture risk |
| Study objectives | To investigate the effects of dietary advice and nutritional supplementation on bone mineral density. |
| Ethics approval(s) | The Research Ethics Committee of the Guys and St Thomas Hospital NHS Trust gave approval |
| Health condition(s) or problem(s) studied | Osteoporosis |
| Intervention | Women meeting the entry criteria will be randomised to one of two groups: 1. A control group will receive calcium/vitamin D only 2. The second group will receive dietary advice and nutritional supplements to increase their dietary intake and calcium/vitamin D |
| Intervention type | Other |
| Primary outcome measure(s) |
Body composition and bone mineral density (BMD), assessed at baseline and 12 months. |
| Key secondary outcome measure(s) |
Biochemical markers of bone turnover, measured at baseline and at 1, 3, 6, 9 and 12 months. |
| Completion date | 31/08/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Female |
| Target sample size at registration | 71 |
| Key inclusion criteria | 1. Women over 70 years 2. Body mass index of less than 21 kg/m^2 3. Osteoporosis at the femoral neck and/or total hip |
| Key exclusion criteria | 1. Evidence of any progressive wasting disease, e.g. carcinomatosis, severe malabsorption 2. Severe renal impairment (estimated glomerular filtration rate [GFR] less than or equal to 45 ml/min) 3. Severe cardiorespiratory diseases 4. Endocrine diseases, e.g., hyperparathyroidism, hyperthyroidism 5. Therapy with drugs known to interfere with bone metabolism such as steroids, vitamin D or its derivatives, bisphosphonates, oestrogen, raloxifene 6. Cognitive impairment (abbreviated mental test score 7 or below) |
| Date of first enrolment | 01/09/1999 |
| Date of final enrolment | 31/08/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Senior Lecturer
London
SE1 7EH
United Kingdom
SE1 7EH
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 | 01/09/2003 | Yes | No |
