|
Welcome
|
|
13 May 2008
|
|
|
| home | my details | ISRCTN Register | mRCT | UKCTG | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Investigating the effect of vitamin K supplementation on markers of bone turnover and bone density in adolescents and adults with cystic fibrosis |
| ISRCTN | ISRCTN14200211 |
| ClinicalTrials.gov identifier | |
| Public title | Investigating the effect of vitamin K supplementation on markers of bone turnover and bone density in adolescents and adults with cystic fibrosis |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | vit K 2006 |
| Study hypothesis | Vitamin K supplementation improves markers of bone turnover and bone density in adolescents and adults with cystic fibrosis (CF). |
| Ethics approval | Ethics approval received from the Wandsworth Research Ethics Committee on the 11th August 2006 (protocol v4), 18th May 2007 (amendments protocol v5) and 3rd August 2007 (amendments protocol v6). |
| Study design | Randomised double-blind placebo-controlled study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Bone health in cystic fibrosis |
| Participants - inclusion criteria |
1. Patients with a diagnosis of CF (positive sweat test or genotype testing)
2. Patients aged greater than 16 years (post pubertal-stage IV Tanner), either sex 3. Patients are pancreatic insufficient (i.e. with a positive faecal elastase test, and requiring pancreatic enzyme supplementation) 4. No evidence of overt liver disease (not on ursodeoxycholic acid) |
| Participants - exclusion criteria |
1. Patients already taking vitamin K supplementation
2. Patients with osteoporosis or osteopaenia and taking bisphosphonates 3. Patients with abnormally low vitamin D levels (less than 30 µg) 4. Patients on maintenance oral corticosteroids 5. Patients who are considered to have very sedentary lifestyle or follow a rigorous exercise training programme 6. Patients with overt liver disease 7. Patients who do not consent to participate 8. Patients with a life expectancy of less than 12 months 9. Patients who are non-compliant with maintenance therapies |
| Anticipated start date | 02/01/2007 |
| Anticipated end date | 09/02/2009 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 40 |
| Interventions |
1. 10 mg of menadiol phosphate (water soluble form of vitamin K) once daily (o.d.) orally for 12 months
2. Matching placebo for 12 months Total duration of treatment and follow-up: 12 months for both arms. |
| Primary outcome measure(s) | The between-groups difference in the ratio of undercarboxylated osteocalcin to total osteocalcin, measured prior to supplementation starting and at the end of the 12 months supplementation. |
| Secondary outcome measure(s) |
The between-group differences in:
1. Total osteocalcin 2. Undercarboxylated osteocalcin 3. N Terminal X (marker of bone resorption) 4. Bone specific alkaline phosphatase 5. Serum vitamin D 6. Calcium 7. Dual energy x-ray absorptiometry (DEXA) scan z and t scores of lumbar spine and femoral neck (scores adjusted for age, height and sex) Measured prior to supplementation starting and at the end of the 12 months supplementation. |
| Sources of funding | Barts and the London NHS Trust (UK) - Internally funded from Nursing, Midwifering and Allied Health Profession research grant |
| Trial website | |
| Publications | |
| Contact name | Dr Lieske Kuitert |
| Address |
Department of Respiratory Medicine
London Chest Hospital Bonner Road |
| City/town | London |
| Zip/Postcode | E2 9JX |
| Country | United Kingdom |
| Sponsor | Barts and the London NHS Trust (UK) |
| Address |
Research and Development Department
24 - 26 Walden Street Whitechapel |
| City/town | London |
| Zip/Postcode | E1 2AN |
| Country | United Kingdom |
| Sponsor website: | http://www.bartsandthelondon.org.uk/ |
| Date applied | 02/04/2008 |
| Last edited | 09/05/2008 |
| Date ISRCTN assigned | 09/05/2008 |
 |
|||
|
|
|
| © ISRCTN | |
|
|
|
|