Vitamin D/K in COPD
- Conditions
- COPD, chronic obstructive pulmonary disease.
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Diagnosed with COPD based on post-bronchodilator FEV1/FVC <0.70 according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
Serum 25(OH)D<50 nmol/L
Age =40 and =75 years at screening visit
Exclusion Criteria
Subjects using vitamin K as supplements <3 months prior to the screening visit
Use of vitamin K antagonists (i.e acenocoumarol, fenprocoumon) in 12 months prior to the screening visit
Exacerbation <6 weeks prior to the screening visit
Use of digoxin and/or thiazide diuretics
Hypercalcemia (i.e. corrected calcium for albumin >2.8 mmol/L)
Kidney stones in medical history
Severe renal failure (i.e. eGFR < 30 ml/min/1.73 m2)
Hyperparathyroidism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the difference in the rate of elastin degradation (quantified by the pDES assay) after 12 weeks of vitamin D/K vs. vitamin D/placebo supplementation.
- Secondary Outcome Measures
Name Time Method Secondary endpoints (after 12 weeks of treatment) are: vitamin K-status (quantified by dp-ucMGP), vitamin D-status (quantified by 25(OH)D), questionnaires concerning health status and dyspnea level, and exacerbations during the study period.