Randomized controlled trial to assess the effect of vitamin K supplementation on the rate of elastin degradation in COPD

Conditions: chronic obstructive pulmonary disease
10024967
COPD

Registration Number: NL-OMON50316

Lead Sponsor: CIRO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

-Written informed consent
- Diagnosed with COPD based on post-bronchodilator FEV1/GVC <0.70 accordig to
the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
-Ability to comply with all study requirements
- Age >40 years

Exclusion Criteria

- Pregnant or lactating women, or subjects who intend to become pregnant within
the study period
-Subjects using vitamin K1 or K2 as supplements
-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 gastro-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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the difference in the rate of elastin degradation after<br /><br>8 weeks of vitamin K supplementation versus placebo (quantified by the plasma<br /><br>desmosine assay).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are vitamin K-status after 8 weeks of treatment (quantified<br /><br>by dp-ucMGP), proteins induced by vitamin K abcense (PIVKA-II) levels<br /><br>(inversely associated with vitamin K status), vitamin D levels, lung function<br /><br>parameters, questionnaires and exacerbations during the study period. In<br /><br>addition, we want to evaluate if different polymorphisms of the VKORC1 gene are<br /><br>associated with desmosine and dp-ucMGP levels at baseline and after vitamin K2<br /><br>supplementation. </p><br>