Vitamin D/K in COPD

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26885

Enrollment

Registered

2019-06-03

Start date

2019-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, chronic obstructive pulmonary disease.

Interventions

Patients are randomized between capsules of vitamin D3 plus vitamin K2 OR capsules of vitamin D3 plus capsule placebo (12 weeks).

Eligibility

Inclusion criteria

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

Exclusion criteria: Subjects using vitamin K as supplements 2.8 mmol/L) Kidney stones in medical history Severe renal failure (i.e. eGFR < 30 ml/min/1.73 m2) Hyperparathyroidism

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Contacts

Public ContactRob Janssen

CWZ

rob.janssen@cwz.nl0031 24 3657944

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)