Vitamin D and Chronic Obstructive Lung Disease

NCT ID: NCT01416701

Last Updated: 2013-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Chronic Obstructive Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Vitamin D (D3, cholecalciferol)

Group Type ACTIVE_COMPARATOR

Vitamin D (D3, cholecalciferol)

Intervention Type DIETARY_SUPPLEMENT

Week 0-4: 152 mcg/daily (4 tablets) Week 5-52: 76 mcg/daily (2 tablets)

Placebo (cellulose)

Group Type PLACEBO_COMPARATOR

Placebo (cellulose)

Intervention Type DIETARY_SUPPLEMENT

Week 0-4: 4 tablets daily Week 4-52: 2 tablets daily

Interventions

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Vitamin D (D3, cholecalciferol)

Week 0-4: 152 mcg/daily (4 tablets) Week 5-52: 76 mcg/daily (2 tablets)

Intervention Type DIETARY_SUPPLEMENT

Placebo (cellulose)

Week 0-4: 4 tablets daily Week 4-52: 2 tablets daily

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Bio Vinci Mega D-vitamin

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jorgen Vestbo

OTHER

Sponsor Role lead

Responsible Party

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Jorgen Vestbo

Prof. DMSc

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jørgen Vestbo, DMSc

Role: PRINCIPAL_INVESTIGATOR

Hvidovre Universityl Hospital

Locations

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Hvidovre University Hospital, Department of Respiratory Medicine

Hvidovre, , Denmark

Site Status

Medical Unit, Hvidovre University Hospital

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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DvitKOL01022011

Identifier Type: -

Identifier Source: org_study_id

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