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Trial record 1 of 1 for:    chronic obstructive pulmonary disease | NCT01416701
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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This study has been withdrawn prior to enrollment.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

August 12, 2011
April 8, 2013
September 2011
October 2013   (final data collection date for primary outcome measure)
  • 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)).
Same as current
Complete list of historical versions of study NCT01416701 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Vitamin D and Chronic Obstructive Lung Disease
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

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Lung Disease
  • 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
  • Dietary Supplement: Placebo (cellulose)
    Week 0-4: 4 tablets daily Week 4-52: 2 tablets daily
  • Active Comparator: Vitamin D (D3, cholecalciferol)
    Intervention: Dietary Supplement: Vitamin D (D3, cholecalciferol)
  • Placebo Comparator: Placebo (cellulose)
    Intervention: Dietary Supplement: Placebo (cellulose)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01416701
DvitKOL01022011
Yes
Jorgen Vestbo, Hvidovre University Hospital
Jorgen Vestbo
Not Provided
Principal Investigator: Jørgen Vestbo, DMSc Hvidovre Universityl Hospital
Hvidovre University Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP