Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease (ViDiCO)

Barts & The London NHS Trust

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Dietary Supplement: Cholecalciferol; Dietary Supplement: Miglyol oil

Study type: Interventional

Funder types: Other

Identifiers

NCT00977873

2009-010084-16

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups, including a placebo group

Vigantol oil

Active Comparator group

Description:

Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year

Treatment:

Dietary Supplement: Cholecalciferol

Miglyol oil

Placebo Comparator group

Description:

Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year

Treatment:

Dietary Supplement: Miglyol oil