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Vitamin D and Chronic Obstructive Lung Disease

This study has been withdrawn prior to enrollment.
(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.)
Sponsor:
Information provided by (Responsible Party):
Jorgen Vestbo, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01416701
First received: August 12, 2011
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Lung Disease
 Dietary Supplement: Vitamin D (D3, cholecalciferol)
Dietary Supplement: Placebo (cellulose)
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Withdrawal from rehabilitation. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Withdrawal will be defined as giving up rehabilitation or delaying any training visit by more than 3 weeks.

  • Improvement in walking distance [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    se-25-OHD se-PTH

  • Change in calcium metabolic status. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    se-calcium se-phosphate se-magnesium

  • Change in quality of life. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    COPD Assessment Test (CAT) and St George Respiratory Questionnaire (SGRQ).

  • Change in status of bone metabolism. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    DXA (Dual energy X-ray Absorptiometry) scans

  • Change in walking distance. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Whole body DXA scans.

  • Change in physical activity. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Physical activity at home is measured over a week using an activity sensor (SenseWear Pro armband).

  • COPD exacerbations. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • All cause hospital admissions. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • All cause mortality. [ Time Frame: 52 weeks. ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D (D3, cholecalciferol) Dietary Supplement: Vitamin D (D3, cholecalciferol)
Week 0-4: 152 mcg/daily (4 tablets) Week 5-52: 76 mcg/daily (2 tablets)
Other Name: Bio Vinci Mega D-vitamin
Placebo Comparator: Placebo (cellulose) Dietary Supplement: Placebo (cellulose)
Week 0-4: 4 tablets daily Week 4-52: 2 tablets daily

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416701

Locations
Denmark
Medical Unit, Hvidovre University Hospital
Hvidovre, Denmark, 2650
Hvidovre University Hospital, Department of Respiratory Medicine
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Jorgen Vestbo
Investigators
Principal Investigator: Jørgen Vestbo, DMSc Hvidovre Universityl Hospital
  More Information

No publications provided

Responsible Party: Jorgen Vestbo, Prof. DMSc, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01416701     History of Changes
Other Study ID Numbers: DvitKOL01022011
Study First Received: August 12, 2011
Last Updated: April 8, 2013
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
COPD
Vitamin D
Pulmonary rehabilitation

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
 Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 21, 2013