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Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease (ViDiCO)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Cholecalciferol

Miglyol oil

About this trial

This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Lower Clapton Health Centre
Homerton University Hospital NHS Foundation Trust
Guy's and St Thomas' NHS Foundation Trust
Barts and The London NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vigantol oil

Miglyol oil

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time to first upper respiratory tract infection

Time to first moderate / severe COPD exacerbation

Secondary Outcome Measures

Time to unscheduled health service use for upper respiratory tract infection or moderate / severe exacerbation of chronic obstructive pulmonary disease

Proportion of participants experiencing hypercalcaemia

Full Information

NCT ID

NCT00977873

First Posted

September 14, 2009

Last Updated

February 3, 2014

Sponsor

Barts & The London NHS Trust

Collaborators

National Health Service, United Kingdom

1. Study Identification

Unique Protocol Identification Number

NCT00977873

Brief Title

Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease

Acronym

ViDiCO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Barts & The London NHS Trust

Collaborators

National Health Service, United Kingdom

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

240 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vigantol oil

Arm Type

Active Comparator

Arm Description

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

Arm Title

Miglyol oil

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Cholecalciferol

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Miglyol oil

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to first upper respiratory tract infection

Time Frame

One year

Title

Time to first moderate / severe COPD exacerbation

Time Frame

One year

Secondary Outcome Measure Information:

Title

Time to unscheduled health service use for upper respiratory tract infection or moderate / severe exacerbation of chronic obstructive pulmonary disease

Time Frame

One year

Title

Proportion of participants experiencing hypercalcaemia

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adrian R Martineau, MRCP

Organizational Affiliation

Queen Mary University of London

Official's Role

Study Director

Facility Information:

Facility Name

Lower Clapton Health Centre

City

London

ZIP/Postal Code

E5 0PD

Country

United Kingdom

Facility Name

Homerton University Hospital NHS Foundation Trust

City

London

ZIP/Postal Code

E9 6SR

Country

United Kingdom

Facility Name

Guy's and St Thomas' NHS Foundation Trust

City

London

ZIP/Postal Code

SE1

Country

United Kingdom

Facility Name

Barts and The London NHS Trust

City

London

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

25476069

Citation

Martineau AR, James WY, Hooper RL, Barnes NC, Jolliffe DA, Greiller CL, Islam K, McLaughlin D, Bhowmik A, Timms PM, Rajakulasingam RK, Rowe M, Venton TR, Choudhury AB, Simcock DE, Wilks M, Degun A, Sadique Z, Monteiro WR, Corrigan CJ, Hawrylowicz CM, Griffiths CJ. Vitamin D3 supplementation in patients with chronic obstructive pulmonary disease (ViDiCO): a multicentre, double-blind, randomised controlled trial. Lancet Respir Med. 2015 Feb;3(2):120-130. doi: 10.1016/S2213-2600(14)70255-3. Epub 2014 Dec 2.

Results Reference

derived

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Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease

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