Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Patients participating in a 8-week inpatient rehabilitation program at CIRO+ will be randomized to receive either 360 mcg vitamin K2 or placebo orally once a day during 8 weeks.
Sponsors
CIRO+ (Centre of expertise for chronic organ failure)
Eligibility
Inclusion criteria
Inclusion criteria: - Written informed consent - Diagnosed with COPD based on post-bronchodilator FEV1/FVC 40 years
Exclusion criteria
Exclusion criteria: - Pregnant or lactating women, or subjects who intend to become pregnant within the study period - Subjects using vitamin K as supplements or multivitamin supplements containing vitamin K - Active malignancy or cured malignancy <12 months prior to enrollment - Use of vitamin K antagonists (acenocoumarol, fenprocoumon) in 12 months prior to inclusion - Expectation of impaired gasto-intestinal uptake of vitamin K such as history of (partial) bowel resection - Serious mental impairment - Exacerbation <2 weeks prior to enrolment. - Life expectation of less than 6 months on the basis of concurrent disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the difference in elastin degradation rate after the intervention between the active and placebo group. Elastin degradation rate is quantified by the change in plasma desmosine levels measured after 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the changes in: vitamin K-status (quantified by dp-ucMGP), proteins induced by vitamin K abcense (PIVKA)-II levels (inversely associated with vitamin K status), vitamin D levels, lung function parameters, questionnaires concerning psychosocial functioning/functional effects/health status, physical functioning, body composition, arterial stiffness and exacerbations during the study period. In addition, we will evaluate if different polymorphisms of the VKORC1 gene are associated with desmosine and dp-ucMGP levels at baseline and after vitamin K2 supplementation. | — |
Contacts
Public ContactFrits Franssen
Postbus 4080
Outcome results
None listed