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Vitamin D and Chronic Obstructive Lung Disease

Primary Purpose

Chronic Obstructive Lung Disease

Status
Withdrawn
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Vitamin D (D3, cholecalciferol)
Placebo (cellulose)
Sponsored by
Jorgen Vestbo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Lung Disease focused on measuring COPD, Vitamin D, Pulmonary rehabilitation

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hvidovre University Hospital, Department of Respiratory Medicine
  • Medical Unit, Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D (D3, cholecalciferol)

Placebo (cellulose)

Arm Description

Outcomes

Primary Outcome Measures

Withdrawal from rehabilitation.
Withdrawal will be defined as giving up rehabilitation or delaying any training visit by more than 3 weeks.
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)).

Secondary Outcome Measures

Change in vitamin D status.
se-25-OHD se-PTH
Change in calcium metabolic status.
se-calcium se-phosphate se-magnesium
Change in quality of life.
COPD Assessment Test (CAT) and St George Respiratory Questionnaire (SGRQ).
Change in status of bone metabolism.
DXA (Dual energy X-ray Absorptiometry) scans
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)).
Change in fat mass and fat free mass.
Whole body DXA scans.
Change in physical activity.
Physical activity at home is measured over a week using an activity sensor (SenseWear Pro armband).
COPD exacerbations.
All cause hospital admissions.
All cause mortality.

Full Information

First Posted
August 12, 2011
Last Updated
April 8, 2013
Sponsor
Jorgen Vestbo
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1. Study Identification

Unique Protocol Identification Number
NCT01416701
Brief Title
Vitamin D and Chronic Obstructive Lung Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Withdrawn
Why Stopped
It was not possible to enroll the planned amount of subjects. Many patients with chronic obstructive pulmonary disease already took large doses of vitamin D.
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jorgen Vestbo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Lung Disease
Keywords
COPD, Vitamin D, Pulmonary rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D (D3, cholecalciferol)
Arm Type
Active Comparator
Arm Title
Placebo (cellulose)
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D (D3, cholecalciferol)
Other Intervention Name(s)
Bio Vinci Mega D-vitamin
Intervention Description
Week 0-4: 152 mcg/daily (4 tablets) Week 5-52: 76 mcg/daily (2 tablets)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo (cellulose)
Intervention Description
Week 0-4: 4 tablets daily Week 4-52: 2 tablets daily
Primary Outcome Measure Information:
Title
Withdrawal from rehabilitation.
Description
Withdrawal will be defined as giving up rehabilitation or delaying any training visit by more than 3 weeks.
Time Frame
24 weeks
Title
Improvement in walking distance
Description
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)).
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in vitamin D status.
Description
se-25-OHD se-PTH
Time Frame
52 weeks
Title
Change in calcium metabolic status.
Description
se-calcium se-phosphate se-magnesium
Time Frame
52 weeks
Title
Change in quality of life.
Description
COPD Assessment Test (CAT) and St George Respiratory Questionnaire (SGRQ).
Time Frame
52 weeks
Title
Change in status of bone metabolism.
Description
DXA (Dual energy X-ray Absorptiometry) scans
Time Frame
52 weeks
Title
Change in walking distance.
Description
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)).
Time Frame
52 weeks
Title
Change in fat mass and fat free mass.
Description
Whole body DXA scans.
Time Frame
52 weeks
Title
Change in physical activity.
Description
Physical activity at home is measured over a week using an activity sensor (SenseWear Pro armband).
Time Frame
24 weeks
Title
COPD exacerbations.
Time Frame
52 weeks
Title
All cause hospital admissions.
Time Frame
52 weeks
Title
All cause mortality.
Time Frame
52 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jørgen Vestbo, DMSc
Organizational Affiliation
Hvidovre Universityl Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital, Department of Respiratory Medicine
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Medical Unit, Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

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Vitamin D and Chronic Obstructive Lung Disease

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