NCT01416701

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2011

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2011

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 9, 2013

Status Verified

April 1, 2013

Enrollment Period

2.1 years

First QC Date

August 12, 2011

Last Update Submit

April 8, 2013

Conditions

Chronic Obstructive Lung Disease

Keywords

COPDVitamin DPulmonary rehabilitation

Outcome Measures

Primary Outcomes (2)

  • Withdrawal from rehabilitation.

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

    24 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)).

    24 weeks

Secondary Outcomes (10)

  • Change in vitamin D status.

    52 weeks

  • Change in calcium metabolic status.

    52 weeks

  • Change in quality of life.

    52 weeks

  • Change in status of bone metabolism.

    52 weeks

  • Change in walking distance.

    52 weeks

  • +5 more secondary outcomes

Study Arms (2)

Vitamin D (D3, cholecalciferol)

ACTIVE COMPARATOR
Dietary Supplement: Vitamin D (D3, cholecalciferol)

Placebo (cellulose)

PLACEBO COMPARATOR
Dietary Supplement: Placebo (cellulose)

Interventions

Vitamin D (D3, cholecalciferol)DIETARY_SUPPLEMENT

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

Also known as: Bio Vinci Mega D-vitamin
Vitamin D (D3, cholecalciferol)
Placebo (cellulose)DIETARY_SUPPLEMENT

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

Placebo (cellulose)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with known diseases of bone metabolism apart from osteoporosis and patients with granulomatous disease
  • 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
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hvidovre University Hospital, Department of Respiratory Medicine

Hvidovre, 2650, Denmark

Location

Medical Unit, Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Vitamin DCholecalciferolCellulose

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipidsGlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Jørgen Vestbo, DMSc

    Hvidovre Universityl Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. DMSc

Study Record Dates

First Submitted

August 12, 2011

First Posted

August 15, 2011

Study Start

September 1, 2011

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

April 9, 2013

Record last verified: 2013-04

Locations

DK(2)