Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
250 participants
INTERVENTIONAL
2009-09-30
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Vigantol oil
Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year
Cholecalciferol
Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
Miglyol oil
Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year
Miglyol oil
Miglyol oil will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
Interventions
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Cholecalciferol
Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
Miglyol oil
Miglyol oil will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 16 years and ≤ 80 years on day of first dose of IMP
* 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 in the study
Exclusion Criteria
* 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
* Any other condition that, in an investigator's judgement, might compromise patient safety or compliance, interfere with evaluation or preclude completion of the study
* Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone
* Taking dietary supplement 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
* Smoking history \>15 pack-years
16 Years
80 Years
ALL
No
Sponsors
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National Health Service, United Kingdom
OTHER_GOV
Barts & The London NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Adrian R Martineau, MRCP
Role: STUDY_DIRECTOR
Queen Mary University of London
Locations
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Barts and The London NHS Trust
London, London, United Kingdom
Lower Clapton Health Centre
London, London, United Kingdom
Homerton University Hospital NHS Foundation Trust
London, London, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, London, United Kingdom
Countries
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References
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Martineau AR, MacLaughlin BD, Hooper RL, Barnes NC, Jolliffe DA, Greiller CL, Kilpin K, McLaughlin D, Fletcher G, Mein CA, Hoti M, Walton R, Grigg J, Timms PM, Rajakulasingam RK, Bhowmik A, Rowe M, Venton TR, Choudhury AB, Simcock DE, Sadique Z, Monteiro WR, Corrigan CJ, Hawrylowicz CM, Griffiths CJ. Double-blind randomised placebo-controlled trial of bolus-dose vitamin D3 supplementation in adults with asthma (ViDiAs). Thorax. 2015 May;70(5):451-7. doi: 10.1136/thoraxjnl-2014-206449. Epub 2015 Feb 27.
Other Identifiers
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2009-010083-42
Identifier Type: -
Identifier Source: org_study_id
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