- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00977873
Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease (ViDiCO)
February 3, 2014 updated by: Barts & The London NHS Trust
Randomised, Multi-Centre, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation in Patients With Chronic Obstructive Pulmonary Disease
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
240
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom, E9 6SR
- Homerton University Hospital NHS Foundation Trust
-
London, United Kingdom
- Barts and the London NHS Trust
-
London, United Kingdom, E5 0PD
- Lower Clapton Health Centre
-
London, United Kingdom, SE1
- Guy's and St Thomas' NHS Foundation Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Miglyol oil
Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year
|
Miglyol oil will be administered in 2-monthly bolus doses over a period of one year
|
Active Comparator: Vigantol oil
Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year
|
Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to first upper respiratory tract infection
Time Frame: One year
|
One year
|
Time to first moderate / severe COPD exacerbation
Time Frame: One year
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of participants experiencing hypercalcaemia
Time Frame: One year
|
One year
|
Time to unscheduled health service use for upper respiratory tract infection or moderate / severe exacerbation of chronic obstructive pulmonary disease
Time Frame: One year
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
September 14, 2009
First Submitted That Met QC Criteria
September 15, 2009
First Posted (Estimate)
September 16, 2009
Study Record Updates
Last Update Posted (Estimate)
February 4, 2014
Last Update Submitted That Met QC Criteria
February 3, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-010084-16
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Obstructive Pulmonary Disease
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Kırıkkale UniversityRecruitingCOPD (Chronic Obstructive Pulmonary Disease)Turkey
-
Hopital FochAir Liquide SARecruitingChronic Obstructive Pulmonary Disease SevereFrance
-
Fundación para la Investigación del Hospital Clínico...Not yet recruitingCOPD, Chronic Obstructive Pulmonary DiseaseSpain
-
Canandaigua VA Medical CenterRecruitingChronic Obstructive Pulmonary Disease ModerateUnited States
Clinical Trials on Cholecalciferol
-
Medical University of South CarolinaTerminatedVitamin D Deficiency | Nutritional DeficiencyUnited States
-
Centre of Postgraduate Medical EducationUnknownInfant, Premature, DiseasesPoland
-
Johns Hopkins UniversityNational Institute on Aging (NIA)TerminatedVitamin D Deficiency | FallsUnited States
-
Rashid Centre for Diabetes and ResearchCompletedObesity | Type 2 Diabetes Mellitus | Hypovitaminosis DUnited Arab Emirates
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)CompletedCystic Fibrosis | Allergic Bronchopulmonary AspergillosisUnited States
-
University Hospitals Cleveland Medical CenterUniversity of Colorado, DenverCompletedInflammationUnited States
-
University Hospital, AngersMylan LaboratoriesCompleted
-
Medical University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
-
Assistance Publique - Hôpitaux de ParisLaboratoire CrinexCompletedRenal Transplant Candidate for Right KidneyFrance