Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

— ViDiCO  

Official title:

Randomised, Multi-Centre, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00977873
• Other study ID #: 2009-010084-16
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 14, 2009
• Last updated: February 3, 2014
• Start date: September 2009
• Est. completion date: July 2013

Study information

• Verified date: February 2014
• Source: Barts & The London NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to moderate/severe exacerbation of chronic obstructive pulmonary disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Principal Inclusion Criteria:

• Medical record diagnosis of COPD, emphysema or bronchitis

• Post-bronchodilator FEV1 / FVC < 70% or post-bronchodilator FEV1 / slow VC < 70%

• Post-bronchodilator FEV1 < 80% predicted

• Age = 40 years on day of first dose of IMP

• Smoking history = 15 pack-years

• If a woman of child-bearing potential, is sexually abstinent or has negative pregnancy test within 7 days of recruitment and agrees to use reliable form of contraception until she has completed the study

• Able to give written informed consent to participate

Exclusion Criteria:

• Current diagnosis of asthma

• Known clinically significant bronchiectasis

• Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin D intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission for = 3 years

• Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone

• Taking dietary supplement or topical preparation containing vitamin D up to 2 months before first dose of IMP

• Treatment with any investigational medical product or device up to 4 months before first dose of IMP

• Breastfeeding, pregnant or planning a pregnancy

• Baseline corrected serum calcium > 2.65 mmol/L

• Baseline serum creatinine > 125 micromol/L

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Dietary Supplement:
• Cholecalciferol
Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
• Miglyol oil
Miglyol oil will be administered in 2-monthly bolus doses over a period of one year

Locations

Country	Name	City	State
United Kingdom	Barts and The London NHS Trust	London
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	Homerton University Hospital NHS Foundation Trust	London
United Kingdom	Lower Clapton Health Centre	London

Sponsors (2)

Lead Sponsor	Collaborator
Barts & The London NHS Trust	National Health Service, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first upper respiratory tract infection		One year	No
Primary	Time to first moderate / severe COPD exacerbation		One year	No
Secondary	Time to unscheduled health service use for upper respiratory tract infection or moderate / severe exacerbation of chronic obstructive pulmonary disease		One year	No
Secondary	Proportion of participants experiencing hypercalcaemia		One year	Yes