Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease (ViDiCO)
This study is ongoing, but not recruiting participants.
Sponsor:
Barts & The London NHS Trust
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: January 31, 2013
Last verified: November 2012
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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 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 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
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: | January 31, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Cholecalciferol Vitamin D |
Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 22, 2013