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Trial record 1 of 1 for:    chronic obstructive pulmonary disease | NCT00977873
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Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease (ViDiCO)

This study has been completed.
Sponsor:
Collaborator:
National Health Service, United Kingdom
Information provided by (Responsible Party):
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT00977873
First received: September 14, 2009
Last updated: February 3, 2014
Last verified: February 2014

September 14, 2009
February 3, 2014
September 2009
July 2013   (final data collection date for primary outcome measure)
  • Time to first upper respiratory tract infection [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Time to first moderate / severe COPD exacerbation [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00977873 on ClinicalTrials.gov Archive Site
  • Time to unscheduled health service use for upper respiratory tract infection or moderate / severe exacerbation of chronic obstructive pulmonary disease [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Proportion of participants experiencing hypercalcaemia [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Chronic Obstructive Pulmonary Disease
  • Dietary Supplement: Cholecalciferol
    Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil 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
  • Active Comparator: Vigantol oil
    Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year
    Intervention: Dietary Supplement: Cholecalciferol
  • Placebo Comparator: Miglyol oil
    Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year
    Intervention: Dietary Supplement: Miglyol oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00977873
2009-010084-16
Yes
Barts & The London NHS Trust
Barts & The London NHS Trust
National Health Service, United Kingdom
Study Director: Adrian R Martineau, MRCP Queen Mary University of London
Barts & The London NHS Trust
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP