Bone health in cystic fibrosis Nutritional, Metabolic, Endocrine Cystic fibrosis
Conditions
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
Sponsors
Barts and the London NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed