Vitamin D Supplementation in Patients With COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT02122627
- Lead Sponsor
- Amsterdam UMC, location VUmc
- Brief Summary
Vitamin D has an immunomodulatory role. the aim of the present study is to assess the effect of vitamin D supplementation on exacerbation rate of COPD patient with a vitamin D deficiency.
- Detailed Description
Rationale: Although vitamin D is well known for its function in calcium homeostasis and bone mineralisation, several studies have shown immunomodulatory effects of vitamin D. Vitamin D deficiency is a common problem in patients with COPD..
Objective: To assess the effect of vitamin D supplementation on exacerbation rate in patients with COPD and a vitamin D deficiency.
Study design: Randomized, multi-center, double-blind, placebo-controlled intervention study.
Study population: 240 patients aged 40 years and older with COPD and a vitamin D deficiency (25-hydroxyvitamin D concentration(25OHD)\<50 nmol/l) with a COPD exacerbation. An exacerbation is defined as sustained worsening of respiratory symptoms during 48 hours and requiring oral corticosteroid, antibiotic or combination treatment that was initiated by a physician. Respiratory symptoms include at least one of the Anthonisen criteria (increased dyspnoea, sputum volume or purulence). Patients with a severe vitamin D deficiency (25OHD\<15 nmol/l), known osteoporosis and/or use of vitamin D supplementation \> 400 IU per day will be excluded.
Intervention: Participants will be randomly allocated to receive vitamin D3 16800 IU or placebo orally once a week during 1 year.
Main study parameters/endpoints: The primary endpoint is exacerbation rate.
Follow-up of the study:
Recruitment of participants is more troublesome than expected due to several reasons, more use of vitamin D supplements, higher 250hydroxyvitamin D levels than anticipated, less suitability due to presence other exclusion criteria.
29/8/2017 total number recruited participants is 119
10/7/2018 closure of recruitment, total number recruited participants is 158
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 158
- written informed consent
- aged above 40 years
- GOLD stages II-IV and diagnosis COPD confirmed by a medical doctor.
- minimum of 10 packyears of smoking
- vitamin D deficiency (a serum 25-hydroxyvitamin D lower than 50 nmol/l)
- ability to comply with all study requirements
- pregnant or lactating women, or subjects who intend to become pregnant within the study period
- self-reported history of hypercalciemia or nephrolithiasis
- self-reported presence of sarcoidosis
- severe vitamin D deficiency (serum 25-hydroxyvitamin D lower than 15 nmol/l)
- life expectation of less than 6 months on the basis of concurrent disease
- interfering malignant diseases.
- diagnosed osteoporosis
- diagnosed asthma
- diagnosed chronic kidney disease stage 4 or higher (estimated glomerular filtration rate ≤ 29 ml/min/1,73 m2)
- serious mental impairment i.e. preventing to understand the study protocol or comply with the study aim; potentially unreliable patients and those judged by the investigator to be unsuitable for the study
- use of maintenance dose oral corticosteroids
- use of multivitamin supplement or vitamin D supplement which contains more than 400 IU per day
- current participation in a clinical rehabilitation programme
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo placebo Vitamin D Vitamin D colecalciferol 16.800 IU per week
- Primary Outcome Measures
Name Time Method Exacerbation rate 1 year Definition of an exacerbation is according to the Anthonisen criteria
- Secondary Outcome Measures
Name Time Method IC 1 year Inspiratory capacity
FRC 1 year Functional residual capacity
RV 1 year Residual volume
TLC 1 year Total lung capacity
MIP 1 year Maximal inspiratory pressure
MEP 1 year Maximal expiratory pressure
FEV1 1 year Forced Expiratory Volume in 1 sec
Time to first and second exacerbation 1 year Time to first and second exacerbation
Time to first hospitalisation 1 year Time to first hospitalisation
Chair stand test 1 year Chair stand test
3-meter walking test 1 year 3-meter walking test
Tandem stand test 1 year Tandem stand test
Quality of life (SGRQ) 1 year QoL by the St George respiratory questionnaire
Quality of life (SF12) 1 year QoL by the 12 item short form survey
Anxiety (HADS) 1 year Anxiety by the hospital anxiety and depression scale
FEV1/FVC 1 year Forced expiratory volume in 1 sec/ forced vital capacity
SMWT 1 year Six-minute walk test
Total score physical function tests 1 year The sum score of the physical function tests
Hand grip strength 1 year Hand grip strength
Depression (CESD) 1 year Depression by the center for epidemiologic studies depression scale
Quality of life (CCQ) 1 year QoL by the Clinical COPD Questionnaire score
Concentrations of antimicrobial peptides and pro-inflammatory mediators in nasal secretions 1 year AMPs in nasal secretions
Ex-vivo cytokine production capacity of peripheral blood mononuclear cells and immunophenotyping 1 year cytokine production capacity by PBMCs
Typing of bacteria and viruses in nasal secretions 1 year Typing of bacteria and viruses in nasal secretions
Use of corticosteroids 1 year Use of corticosteroids
Use of antibiotics 1 year Use of antibiotics
Physical activity (SQUASH) 1 year physical activity by short questionnaire to assess health-enhancing physical activity
Trial Locations
- Locations (2)
Radboud University Medical Center
🇳🇱Nijmegen, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands