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

Location not identified by Google services

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

Medical Conditions
  • Asthma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT00978315
Primary Trial ID Number

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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.
Research Details
    Sorry, this information is not available
Phase
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
Interventional
Intervention
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
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
16 Years - 80 Years
Who Can Participate
Patients
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
GSK Investigational Site
London
E1 1BB
Guy's Hospital
London
SE1 9RT
London
E9 6SR
Lower Clapton Health Centre
London
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
Funder(s)
  • National Health Service, United Kingdom
Other Study ID Numbers
2009-010083-42
Sponsor(s)
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 added to source

14 Sep 2009

Date updated in source

03 Feb 2014