Vitamin D and Chronic Obstructive Lung Disease
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|ClinicalTrials.gov Identifier: NCT01416701|
Recruitment Status : Withdrawn (It was not possible to enroll the planned amount of subjects.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.)
First Posted : August 15, 2011
Last Update Posted : April 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Lung Disease||Dietary Supplement: Vitamin D (D3, cholecalciferol) Dietary Supplement: Placebo (cellulose)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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 Start Date :||September 2011|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||December 2013|
|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
- Withdrawal from rehabilitation. [ Time Frame: 24 weeks ]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 ]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)).
- Change in vitamin D status. [ Time Frame: 52 weeks ]se-25-OHD se-PTH
- Change in calcium metabolic status. [ Time Frame: 52 weeks ]se-calcium se-phosphate se-magnesium
- Change in quality of life. [ Time Frame: 52 weeks ]COPD Assessment Test (CAT) and St George Respiratory Questionnaire (SGRQ).
- Change in status of bone metabolism. [ Time Frame: 52 weeks ]DXA (Dual energy X-ray Absorptiometry) scans
- Change in walking distance. [ Time Frame: 52 weeks ]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 ]Whole body DXA scans.
- Change in physical activity. [ Time Frame: 24 weeks ]Physical activity at home is measured over a week using an activity sensor (SenseWear Pro armband).
- COPD exacerbations. [ Time Frame: 52 weeks ]
- All cause hospital admissions. [ Time Frame: 52 weeks ]
- All cause mortality. [ Time Frame: 52 weeks. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416701
|Hvidovre University Hospital, Department of Respiratory Medicine|
|Hvidovre, Denmark, 2650|
|Medical Unit, Hvidovre University Hospital|
|Hvidovre, Denmark, 2650|
|Principal Investigator:||Jørgen Vestbo, DMSc||Hvidovre Universityl Hospital|