To investigate the effect of vitamin K supplementation on markers of bone turnover and bone density in adolescents and adults with cystic fibrosis - Vitamin K supplementation in Cystic Fibrosis

Phase 1

• Conditions: Cystic Fibrosis; MedDRA version: 8.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis

• Registration Number: EUCTR2006-000945-20-GB
• Lead Sponsor: Barts and the London NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-18
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Patients with a diagnosis of CF (positive sweat test and genotype testing)
Patients aged over 16 years (post pubertal-stage IV Tanner)
Patients who are pancreatic insufficient (i.e. with a positive faecal elastase test and requiring pancreatic enzyme supplementation)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients already taking vitamin K supplementation,
Patients with abnormally low vitamin D levels (<30 µg)
Patients on maintenance oral corticosteroids
Patients with osteopaenia or osteoporosis and taking bisphosphonates
Patients who are considered to have very sedentary lifestyle or follow a rigorous exercise training programme
Patients with overt liver disease
Patients who do not consent to participate
Patients with a life expectancy of less than 12 months
Patients who are non-compliant with maintenance therapies

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified