Vitamin D and Chronic Obstructive Lung Disease

Jorgen Vestbo

Status and phase: Withdrawn; Phase 4

Conditions: Chronic Obstructive Lung Disease

Treatments: Dietary Supplement: Vitamin D (D3, cholecalciferol); Dietary Supplement: Placebo (cellulose)

Study type: Interventional

Funder types: Other

Identifiers

NCT01416701

DvitKOL01022011

Details and patient eligibility

About

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

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Vitamin D (D3, cholecalciferol)

Active Comparator group

Treatment:

Dietary Supplement: Vitamin D (D3, cholecalciferol)

Placebo (cellulose)

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo (cellulose)