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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	25 November 2019
Main ID:	EUCTR2006-000945-20-GB
Date of registration:	18/09/2006
Prospective Registration:	No
Primary sponsor:	Barts and the London NHS Trust
Public title:	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
Scientific title:	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
Date of first enrolment:	22/08/2006
Target sample size:	40
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000945-20
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment
United Kingdom

Contacts

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Key inclusion & exclusion 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:
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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Trade Name: Menadiol Diphosphate
Product Name: Menadiol Diphosphate
Product Code: Menadiol Diphosphate
Pharmaceutical Form: Capsule*
INN or Proposed INN: Menadiol sodium diphosphate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To establish whether vitamin K supplementation in adolescent and adult patients with CF improves markers of bone formation.

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

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.

Secondary Outcome(s)

Secondary ID(s)

vitk2006

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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