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

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ClinicalTrials.gov Identifier: NCT00977873
Recruitment Status : Completed
First Posted : September 16, 2009
Last Update Posted : February 4, 2014
Sponsor:
Collaborator:
National Health Service, United Kingdom
Information provided by (Responsible Party):
Barts & The London NHS Trust

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : September 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Time to first upper respiratory tract infection [ Time Frame: One year ]
  2. Time to first moderate / severe COPD exacerbation [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Time to unscheduled health service use for upper respiratory tract infection or moderate / severe exacerbation of chronic obstructive pulmonary disease [ Time Frame: One year ]
  2. Proportion of participants experiencing hypercalcaemia [ Time Frame: One year ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00977873


Locations
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United Kingdom
Lower Clapton Health Centre
London, United Kingdom, E5 0PD
Homerton University Hospital NHS Foundation Trust
London, United Kingdom, E9 6SR
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1
Barts and The London NHS Trust
London, United Kingdom
Sponsors and Collaborators
Barts & The London NHS Trust
National Health Service, United Kingdom
Investigators
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Study Director: Adrian R Martineau, MRCP Queen Mary University of London
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT00977873    
Other Study ID Numbers: 2009-010084-16
First Posted: September 16, 2009    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Cholecalciferol
Calcium-Regulating Hormones and Agents
 Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents