Vitamin D and Chronic Obstructive Lung Disease

Chronic Obstructive Lung Disease Clinical Trial

Official title:

Vitamin D and COPD. A Randomised, Double-blind, Placebo-controlled Trial of the Effect of Vitamin D on Withdrawal From Pulmonary Rehabilitation and Exercise Endurance

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01416701
• Other study ID #: DvitKOL01022011
• Status: Withdrawn
• Phase: Phase 4
• First received: August 12, 2011
• Last updated: April 8, 2013
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2013
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Lung Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Dietary Supplement:
• Vitamin D (D3, cholecalciferol)
Week 0-4: 152 mcg/daily (4 tablets) Week 5-52: 76 mcg/daily (2 tablets)
• Placebo (cellulose)
Week 0-4: 4 tablets daily Week 4-52: 2 tablets daily

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital, Department of Respiratory Medicine	Hvidovre
Denmark	Medical Unit, Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Jorgen Vestbo

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Withdrawal from rehabilitation.	Withdrawal will be defined as giving up rehabilitation or delaying any training visit by more than 3 weeks.	24 weeks	No
Primary	Improvement in walking distance	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)).	24 weeks	No
Secondary	Change in vitamin D status.	se-25-OHD se-PTH	52 weeks	No
Secondary	Change in calcium metabolic status.	se-calcium se-phosphate se-magnesium	52 weeks	Yes
Secondary	Change in quality of life.	COPD Assessment Test (CAT) and St George Respiratory Questionnaire (SGRQ).	52 weeks	No
Secondary	Change in status of bone metabolism.	DXA (Dual energy X-ray Absorptiometry) scans	52 weeks	No
Secondary	Change in walking distance.	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)).	52 weeks	No
Secondary	Change in fat mass and fat free mass.	Whole body DXA scans.	52 weeks	No
Secondary	Change in physical activity.	Physical activity at home is measured over a week using an activity sensor (SenseWear Pro armband).	24 weeks	No
Secondary	COPD exacerbations.		52 weeks	No
Secondary	All cause hospital admissions.		52 weeks	No
Secondary	All cause mortality.		52 weeks.	No