Investigating the effect of vitamin K supplementation on markers of bone turnover and bone density in adolescents and adults with cystic fibrosis

Not Applicable

Completed

• Conditions: Bone health in cystic fibrosis; Nutritional, Metabolic, Endocrine; Cystic fibrosis

• Registration Number: ISRCTN14200211
• Lead Sponsor: Barts and the London NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-09
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified