Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease (ViDiCO)
This study has been completed.
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: February 3, 2014
Last verified: February 2014
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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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977873
Locations
| United Kingdom | |
| Barts and The London NHS Trust | |
| London, United Kingdom | |
| Guy's and St Thomas' NHS Foundation Trust | |
| London, United Kingdom, SE1 | |
| Homerton University Hospital NHS Foundation Trust | |
| London, United Kingdom, E9 6SR | |
| Lower Clapton Health Centre | |
| London, United Kingdom, E5 0PD | |
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 Bone Density Conservation Agents |
Growth Substances Micronutrients Pharmacologic Actions Physiological Effects of Drugs Vitamins |
ClinicalTrials.gov processed this record on March 01, 2015