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Main
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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. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN14200211 |
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Date of registration:
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09/05/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Investigating the effect of vitamin K supplementation on markers of bone turnover and bone density in adolescents and adults with cystic fibrosis
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Scientific title:
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Investigating the effect of vitamin K supplementation on markers of bone turnover and bone density in adolescents and adults with cystic fibrosis |
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Date of first enrolment:
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02/01/2007 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN14200211 |
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Study type:
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Interventional |
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Study design:
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Randomised double-blind placebo-controlled study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Lieske
Kuitert |
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Address:
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Department of Respiratory Medicine
London Chest Hospital
Bonner Road
E2 9JX
London
United Kingdom |
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Affiliation:
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Key inclusion & exclusion criteria
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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)
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bone health in cystic fibrosis
Nutritional, Metabolic, Endocrine
Cystic fibrosis
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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vit K 2006
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Source(s) of Monetary Support
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Barts and the London NHS Trust (UK) - Internally funded from Nursing, Midwifering and Allied Health Profession research grant
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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