Trial of Vitamin D Supplementation in Asthma | Completed
Trial of Vitamin D Supplementation in Asthma
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Asthma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Recruitment Status
Primary Trial ID Number
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.
Research Details
    Sorry, this information is not available
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Study Type
Dietary Supplement : Cholecalciferol, Dietary Supplement : Miglyol oil

Study Arm Groups : Vigantol oil, Miglyol oil

Intervention Type
See Interventions above
Primary Outcome Measures
  • Time to first upper respiratory tract infection; One year; Time to first severe asthma exacerbation; One year
Secondary Outcome Measures
  • Asthma Control Test Score; One year; Time to unscheduled health service use for upper respiratory tract infection or severe asthma exacerbation; One year; Proportion of participants experiencing hypercalcaemia; One year
Sorry, this information is not available
Result Reports
This is available on the website
Age Range
16 Years - 80 Years
Who Can Participate
Number of Participants
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Guy's Hospital
Homerton University Hospital
E9 6SR
Pfizer Investigational Site
E1 1BB
Lower Clapton Health Centre
E5 0PD
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
Randomised, Multi-centre, Double-blind, Placebo-controlled Trial of Vitamin D Supplementation in Adult and Adolescent Patients With Asthma
EudraCT Number
Not available for this trial
  • National Health Service, United Kingdom
Other Study ID Numbers
Barts & The London NHS Trust
Key Dates

Recruitment Start Date

Sep 2009

Recruitment End Date

Jul 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

14 Sep 2009

Last Updated

03 Feb 2014