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
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
Dietary Supplement: Cholecalciferol
Dietary Supplement: Miglyol oil
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 240
Study Start Date: September 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977873

Locations
United Kingdom
Barts and The London NHS Trust
London, United Kingdom
Homerton University Hospital NHS Foundation Trust
London, United Kingdom, E9 6SR
Lower Clapton Health Centre
London, United Kingdom, E5 0PD
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1
Sponsors and Collaborators
Barts & The London NHS Trust
National Health Service, United Kingdom
Investigators
Study Director: Adrian R Martineau, MRCP Queen Mary University of London
  More Information

No publications provided

Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT00977873     History of Changes
Other Study ID Numbers: 2009-010084-16
Study First Received: September 14, 2009
Last Updated: February 3, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Cholecalciferol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 01, 2014