Chronic obstructive pulmonary disease (COPD) MedDRA version: 14.1 Level: LLT Classification code 10009032 Term: Chronic obstructive lung disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: BioVinci Mega D-vitamin 38 mcg
Pharmaceutical Form: Tablet
INN or Proposed INN: COLECALCIFEROL
CAS Number: 67-97-0
Concentration unit: µg microgram(s)
Concentration type: equal
Concentrat
Sponsors
Hvidovre Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age = 50 years 2) Diagnosed COPD with forced expiratory volume in 1 second (FEV1) =65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: 1) Patients with known diseases of bone metabolism apart from osteoporosis and patients with granulomatous disease 2) Patients with hyper- or hypocalcemia at inclusion 3) Patients with cardiovascular or musculoskeletal disease that impacts significantly on walking based on the investigator’s judgement 4) Patients with dementia or other mental conditions rendering them unable to understand the study information and thus provide informed consent 5) Patients with terminal disease or known cancer with bone metastases, increasing their risk of hypercalcemia 6) Patients taking more than 20 µg vtamin D on a daily basis who do not have vitamin D (serum 25-OHD) less than 40 nnmol/L. If a patient takes vitamin D, dose should have been stable 6 months prior to inclusion in order to achieve steady-state. 7) Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine the effect of vitamin D intervention in patients with chronic obstructive pulmonary disease (COPD) undergoing rehabilitation. The main objective being examination of the effect on withdrawal rates and walking distance ;Secondary Objective: To examine the effect of vitamin D in patients with COPD relating to bone health, inflammation, health related quality of life, and infection;Primary end point(s): 1) Withdrawal rate from pulmonary rehabilitation 2) Walking distance assessed by ISWT and ESWT ;Timepoint(s) of evaluation of this end point: After 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Vitamin D status: se-25-OHD, se-PTH 2) Calcium metabolic status: se-calcium, se-fosfat and se-magnesium 3) Quality of life (CAT og SGRQ) 4) Bone metabolic status: Se-ICTP, -PINP and osteocalcin. BMD L1-L4 and BMD total hip (DXA-scan) 5) Fat free mass and fat mass: DXA-scan 6) Physical activity assessed by SenseWear Armband 7) COPD excacerbations, all hospital admissions and death;Timepoint(s) of evaluation of this end point: After 11 weeks, 24 weeks and 52 weeks | — |
Countries
Denmark
Contacts
Public ContactLungemedicinsk Sektion
Hvidovre Hospital
Outcome results
None listed