ViDiCO: Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease

Sponsor

Barts & The London NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT00977873

Collaborator

National Health Service, United Kingdom (Other)

240

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Dietary Supplement: Cholecalciferol Dietary Supplement: Miglyol oil	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vigantol oil Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year	Dietary Supplement: Cholecalciferol Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
Placebo Comparator: Miglyol oil Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year	Dietary Supplement: Miglyol oil Miglyol oil will be administered in 2-monthly bolus doses over a period of one year

Arm

Intervention/Treatment

Active Comparator: Vigantol oil

Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year

Dietary Supplement: Cholecalciferol

Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year

Placebo Comparator: Miglyol oil

Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year

Dietary Supplement: Miglyol oil

Miglyol oil will be administered in 2-monthly bolus doses over a period of one year

Outcome Measures

Primary Outcome Measures

Time to first upper respiratory tract infection [One year]
Time to first moderate / severe COPD exacerbation [One year]

Secondary Outcome Measures

Time to unscheduled health service use for upper respiratory tract infection or moderate / severe exacerbation of chronic obstructive pulmonary disease [One year]
Proportion of participants experiencing hypercalcaemia [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Lower Clapton Health Centre	London	United Kingdom	E5 0PD
2	Homerton University Hospital NHS Foundation Trust	London	United Kingdom	E9 6SR
3	Guy's and St Thomas' NHS Foundation Trust	London	United Kingdom	SE1
4	Barts and The London NHS Trust	London	United Kingdom