Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/04/2008
Date assigned
09/05/2008
Last edited
27/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lieske Kuitert

ORCID ID

Contact details

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

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 measures

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

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

http://www.bartsandthelondon.org.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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