Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
vit K 2006
Study information
Scientific title
Investigating the effect of vitamin K supplementation on markers of bone turnover and bone density in adolescents and adults with cystic fibrosis
Acronym
Study hypothesis
Vitamin K supplementation improves markers of bone turnover and bone density in adolescents and adults with cystic fibrosis (CF).
Ethics approval
Wandsworth Research Ethics Committee, 11/08/2006 (protocol v4), 18/05/2007 (amendments protocol v5) and 03/08/2007 (amendments protocol v6).
Study design
Randomised double-blind placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Bone health in cystic fibrosis
Intervention
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.
Intervention type
Supplement
Phase
Not Applicable
Drug names
Vitamin K supplementation
Primary outcome measure
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 measures
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.
Overall trial start date
02/01/2007
Overall trial end date
09/02/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
02/01/2007
Recruitment end date
09/02/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Respiratory Medicine
London
E2 9JX
United Kingdom
Sponsor information
Organisation
Barts and the London NHS Trust (UK)
Sponsor details
Research and Development Department
24 - 26 Walden Street
Whitechapel
London
E1 2AN
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Barts and the London NHS Trust (UK) - Internally funded from Nursing, Midwifering and Allied Health Profession research grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list