Vitamin D and Chronic Obstructive Lung Disease

Phase 4

Withdrawn

• Conditions: Chronic Obstructive Lung Disease

• Registration Number: NCT01416701
• Lead Sponsor: Jorgen Vestbo

Brief Summary

The purpose of this study is to examine the effect of vitamin D intervention in patients with chronic obstructive pulmonary disease (COPD) undergoing rehabilitation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-12
• Study First Submitted QC: 2011-08-12
• Study First Posted: 2011-08-15
• Study Start: 2011-09
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-08
• Last Update Posted: 2013-04-09
• Primary Completion: 2013-10
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age ≥ 50 years
• Diagnosed COPD with forced expiratory volume in 1 second (FEV1) < 50 % of predicted
• Breathlessness relative to MRC dyspnoea grade 3 or more

Exclusion Criteria

• Patients with known diseases of bone metabolism apart from osteoporosis and patients with granulomatous disease
• Patients with hyper- or hypocalcemia at inclusion
• Patients with cardiovascular or musculoskeletal disease that impacts significantly on walking based on the investigator's judgement
• Patients with dementia or other mental conditions rendering them unable to understand the study information and thus provide informed consent
• Patients with terminal disease or known cancer with bone metastases, increasing their risk of hypercalcemia
• Patients taking more than 20 mcg vitamin D on a daily basis. If a patient takes vitamin D below this limit, dose should have been stable 6 months prior to inclusion in order to achieve steady-state.
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Withdrawal from rehabilitation.	24 weeks	Withdrawal will be defined as giving up rehabilitation or delaying any training visit by more than 3 weeks.
Improvement in walking distance	24 weeks	Change in walking distance from week 0 to week 24. Exercise capacity is evaluated using paced walking (Incremental Shuttle Walk Test(ISWT) and Endurance Shuttle Walk Test (ESWT)).

Secondary Outcome Measures

Name	Time	Method
Change in vitamin D status.	52 weeks	se-25-OHD se-PTH
Change in calcium metabolic status.	52 weeks	se-calcium se-phosphate se-magnesium
Change in quality of life.	52 weeks	COPD Assessment Test (CAT) and St George Respiratory Questionnaire (SGRQ).
Change in status of bone metabolism.	52 weeks	DXA (Dual energy X-ray Absorptiometry) scans
Change in walking distance.	52 weeks	Change in walking distance from week 0 to week 11 and week 52. Exercise capacity is evaluated using paced walking (Incremental Shuttle Walk Test (ISWT) and Endurance Shuttle Walk Test (ESWT)).
Change in fat mass and fat free mass.	52 weeks	Whole body DXA scans.
Change in physical activity.	24 weeks	Physical activity at home is measured over a week using an activity sensor (SenseWear Pro armband).
COPD exacerbations.	52 weeks
All cause hospital admissions.	52 weeks
All cause mortality.	52 weeks.

Trial Locations

Locations (2)

Hvidovre University Hospital, Department of Respiratory Medicine; 🇩🇰 Hvidovre, Denmark

Medical Unit, Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark