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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000945-20-GB

Enrollment

Registered

2006-09-18

Start date

2006-08-22

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Menadiol Diphosphate Product Name: Menadiol Diphosphate Product Code: Menadiol Diphosphate Pharmaceutical Form: Capsule* INN

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To establish whether vitamin K supplementation in adolescent and adult patients with CF improves markers of bone formation. ; Secondary Objective: To assess vitamin K deficiency in our population of CF adolescent and adult patients. To determine if vitamin K supplementation improves bone density in adolescent and adult CF patients. ; Primary end point(s): Differences between treatment and control group of the ratio of undercarboxylated osteocalcin to total osteocalcin following supplementation of menadiol phosphate. Differences between treatment and control group of the t scores from bone densitometry scans following supplementation of menadiol phosphate	—

Measure

Time frame

Main Objective: To establish whether vitamin K supplementation in adolescent and adult patients with CF improves markers of bone formation. ; Secondary Objective: To assess vitamin K deficiency in our population of CF adolescent and adult patients. To determine if vitamin K supplementation improves bone density in adolescent and adult CF patients. ; Primary end point(s): Differences between treatment and control group of the ratio of undercarboxylated osteocalcin to total osteocalcin following supplementation of menadiol phosphate. Differences between treatment and control group of the t scores from bone densitometry scans following supplementation of menadiol phosphate

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026