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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease | Dietary Supplement: Cholecalciferol Dietary Supplement: Miglyol oil | Phase 2 Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Vigantol oil
Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year
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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
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Dietary Supplement: Miglyol oil
Miglyol oil will be administered in 2-monthly bolus doses over a period of one year |
- Time to first upper respiratory tract infection [ Time Frame: One year ]
- Time to first moderate / severe COPD exacerbation [ Time Frame: One year ]
- Time to unscheduled health service use for upper respiratory tract infection or moderate / severe exacerbation of chronic obstructive pulmonary disease [ Time Frame: One year ]
- Proportion of participants experiencing hypercalcaemia [ Time Frame: One year ]

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Study Director: | Adrian R Martineau, MRCP | Queen Mary University of London |
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 |
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 |