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

ISRCTN	ISRCTN14200211
DOI	https://doi.org/10.1186/ISRCTN14200211
Secondary identifying numbers	vit K 2006

Submission date: 02/04/2008
Registration date: 09/05/2008
Last edited: 27/04/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Lieske Kuitert
Scientific

Department of Respiratory Medicine
London Chest Hospital
Bonner Road
London
E2 9JX
United Kingdom

Study information

Study design	Randomised double-blind placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Investigating the effect of vitamin K supplementation on markers of bone turnover and bone density in adolescents and adults with cystic fibrosis
Study objectives	Vitamin K supplementation improves markers of bone turnover and bone density in adolescents and adults with cystic fibrosis (CF).
Ethics approval(s)	Wandsworth Research Ethics Committee, 11/08/2006 (protocol v4), 18/05/2007 (amendments protocol v5) and 03/08/2007 (amendments protocol v6).
Health condition(s) or problem(s) studied	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
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 study start date	02/01/2007
Completion date	09/02/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40
Key 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)
Key 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
Date of first enrolment	02/01/2007
Date of final enrolment	09/02/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Respiratory Medicine

London
E2 9JX
United Kingdom

Sponsor information

Barts and the London NHS Trust (UK)
Hospital/treatment centre

Research and Development Department
24 - 26 Walden Street
Whitechapel
London
E1 2AN
England
United Kingdom

Website	http://www.bartsandthelondon.org.uk/
"ROR"	https://ror.org/00b31g692

Funders

Funder type

Government

Barts and the London NHS Trust (UK) - Internally funded from Nursing, Midwifering and Allied Health Profession research grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

27/04/2016: No publications found, verifying study status with principal investigator