Back to resultsTrial of Vitamin D Supplementation in Asthma (ViDiAs)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Cholecalciferol
Miglyol oil
Sponsored by
About this trial
This is an interventional prevention trial for Asthma
Eligibility Criteria
Principal Inclusion Criteria:
- Medical record diagnosis of asthma
- 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
Principal Exclusion Criteria:
- Diagnosis of COPD
- 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
Sites / Locations
- Barts and The London NHS Trust
- Lower Clapton Health Centre
- Homerton University Hospital NHS Foundation Trust
- Guy's and St Thomas' NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vigantol oil
Miglyol oil
Arm Description
Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year
Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year
Outcomes
Primary Outcome Measures
Time to first upper respiratory tract infection
Time to first severe asthma exacerbation
Secondary Outcome Measures
Asthma Control Test Score
Time to unscheduled health service use for upper respiratory tract infection or severe asthma exacerbation
Proportion of participants experiencing hypercalcaemia
Full Information
NCT ID
NCT00978315
First Posted
September 14, 2009
Last Updated
February 3, 2014
Sponsor
Barts & The London NHS Trust
Collaborators
National Health Service, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT00978315
Brief Title
Trial of Vitamin D Supplementation in Asthma
Acronym
ViDiAs
Official Title
Randomised, Multi-centre, Double-blind, Placebo-controlled Trial of Vitamin D Supplementation in Adult and Adolescent Patients With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barts & The London NHS Trust
Collaborators
National Health Service, United Kingdom
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to severe asthma exacerbation in adult and adolescent patients with asthma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vigantol oil
Arm Type
Active Comparator
Arm Description
Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year
Arm Title
Miglyol oil
Arm Type
Placebo Comparator
Arm Description
Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol
Intervention Description
Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
Intervention Type
Dietary Supplement
Intervention Name(s)
Miglyol oil
Intervention Description
Miglyol oil will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
Primary Outcome Measure Information:
Title
Time to first upper respiratory tract infection
Time Frame
One year
Title
Time to first severe asthma exacerbation
Time Frame
One year
Secondary Outcome Measure Information:
Title
Asthma Control Test Score
Time Frame
One year
Title
Time to unscheduled health service use for upper respiratory tract infection or severe asthma exacerbation
Time Frame
One year
Title
Proportion of participants experiencing hypercalcaemia
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Principal Inclusion Criteria:
Medical record diagnosis of asthma
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
Principal Exclusion Criteria:
Diagnosis of COPD
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian R Martineau, MRCP
Organizational Affiliation
Queen Mary University of London
Official's Role
Study Director
Facility Information:
Facility Name
Barts and The London NHS Trust
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Lower Clapton Health Centre
City
London
ZIP/Postal Code
E5 0PD
Country
United Kingdom
Facility Name
Homerton University Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
E9 6SR
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
25724847
Citation
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.
Results Reference
derived
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Trial of Vitamin D Supplementation in Asthma
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