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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Obstructive Lung Disease
• Intervention / Treatment: Dietary supplement: Vitamin D (D3, cholecalciferol); Dietary supplement: Placebo (cellulose)

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Hvidovre University Hospital, Department of Respiratory Medicine
  • Hvidovre, Denmark, 2650
    • Medical Unit, Hvidovre University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vitamin D status.	se-25-OHD se-PTH	52 weeks
Change in calcium metabolic status.	se-calcium se-phosphate se-magnesium	52 weeks
Change in quality of life.	COPD Assessment Test (CAT) and St George Respiratory Questionnaire (SGRQ).	52 weeks
Change in status of bone metabolism.	DXA (Dual energy X-ray Absorptiometry) scans	52 weeks
Change in walking distance.	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)).	52 weeks
Change in fat mass and fat free mass.	Whole body DXA scans.	52 weeks
Change in physical activity.	Physical activity at home is measured over a week using an activity sensor (SenseWear Pro armband).	24 weeks
COPD exacerbations.		52 weeks
All cause hospital admissions.		52 weeks
All cause mortality.		52 weeks.

Collaborators and Investigators

• Sponsor: Jorgen Vestbo
• Investigators: Principal Investigator: Jørgen Vestbo, DMSc, Hvidovre Universityl Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): October 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: August 12, 2011
• First Submitted That Met QC Criteria: August 12, 2011
• First Posted (Estimate): August 15, 2011

Study Record Updates

• Last Update Posted (Estimate): April 9, 2013
• Last Update Submitted That Met QC Criteria: April 8, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Vitamin D; COPD; Pulmonary rehabilitation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins
• Other Study ID Numbers: DvitKOL01022011