Effect of vitamin D supplementation on pulmonary function, airway infections and physical performance in patients with COPD: a randomized controlled trial

Effect of vitamin D supplementation on pulmonary function, airway infections and physical performance in patients with COPD: a randomized controlled trial - Vitamin D supplementation and pulmonary function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38400

Enrollment

120

Registered

2011-11-01

Start date

2012-02-17

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

chronic bronchitis Chronic obstructive pulmonary disease

Interventions

The intervention group will receive vitamin D3 1200 IU orally once a day. The control group will receive a placebo orally once a day.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Written informed consent - Aged between 40 and 70 years - Postbronchodilator FEV1/FVC

Exclusion criteria

Exclusion criteria: - Severe vitamin D deficiency (serum 25-hydroxyvitamin D

Design outcomes

Primary

Measure	Time frame
The primary endpoints are respiratory muscle strength (MIP and MEP) and scores on physical performance tests.	—

Secondary

Measure	Time frame
Secondary endpoints are pulmonary function (FEV1 and FEV1/FVC), peak flow measurements, scores on muscle strength tests, incidence of exacerbations, concentrations of antimicrobial peptides in nasal seretion, bacterial and viral nasal colonization, levels of inflammatory markers in sputum, and the scores of the LASA physical activity questionnaire (LAPAQ), functional limitations questionnaire, the Short Form 12-item Health Survey (SF-12) and the EQ-5D.	—

Measure

Time frame

Secondary endpoints are pulmonary function (FEV1 and FEV1/FVC), peak flow measurements, scores on muscle strength tests, incidence of exacerbations, concentrations of antimicrobial peptides in nasal seretion, bacterial and viral nasal colonization, levels of inflammatory markers in sputum, and the scores of the LASA physical activity questionnaire (LAPAQ), functional limitations questionnaire, the Short Form 12-item Health Survey (SF-12) and the EQ-5D.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)