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ViDiAs: Trial of Vitamin D Supplementation in Asthma

Sponsor
Barts & The London NHS Trust (Other)
Overall Status
Completed
CT.gov ID
NCT00978315
Collaborator
National Health Service, United Kingdom (Other)
250
Enrollment
4
Locations
2
Arms
46
Duration (Months)
62.5
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Cholecalciferol
  • Dietary Supplement: Miglyol oil
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
250 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 Adult and Adolescent Patients With Asthma
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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 as 2-monthly oral bolus doses of Vigantol oil over a period of one year

Outcome Measures

Primary Outcome Measures

  1. Time to first upper respiratory tract infection [One year]

  2. Time to first severe asthma exacerbation [One year]

Secondary Outcome Measures

  1. Asthma Control Test Score [One year]

  2. Time to unscheduled health service use for upper respiratory tract infection or severe asthma exacerbation [One year]

  3. Proportion of participants experiencing hypercalcaemia [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Barts and The London NHS Trust London United Kingdom E1 1BB
2 Lower Clapton Health Centre London United Kingdom E5 0PD
3 Homerton University Hospital NHS Foundation Trust London United Kingdom E9 6SR
4 Guy's and St Thomas' NHS Foundation Trust London United Kingdom SE1 9RT

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT00978315
Other Study ID Numbers:
  • 2009-010083-42
First Posted:
Sep 16, 2009
Last Update Posted:
Feb 4, 2014
Last Verified:
Feb 1, 2014
Additional relevant MeSH terms:
Asthma
Cholecalciferol
Vitamin D

Study Results

No Results Posted as of Feb 4, 2014