Trial of Vitamin D Supplementation in Asthma (ViDiAs)

February 3, 2014 updated by: Barts & The London NHS Trust

Randomised, Multi-centre, Double-blind, Placebo-controlled Trial of Vitamin D Supplementation in Adult and Adolescent Patients With Asthma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Guy's and St Thomas' NHS Foundation Trust
      • London, United Kingdom, E9 6SR
        • Homerton University Hospital NHS Foundation Trust
      • London, United Kingdom, E1 1BB
        • Barts and the London NHS Trust
      • London, United Kingdom, E5 0PD
        • Lower Clapton Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first upper respiratory tract infection
Time Frame: One year
One year
Time to first severe asthma exacerbation
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Asthma Control Test Score
Time Frame: One year
One year
Time to unscheduled health service use for upper respiratory tract infection or severe asthma exacerbation
Time Frame: One year
One year
Proportion of participants experiencing hypercalcaemia
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts & The London NHS Trust

Collaborators

National Health Service, United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

September 14, 2009

First Submitted That Met QC Criteria

September 15, 2009

First Posted (ESTIMATE)

September 16, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 4, 2014

Last Update Submitted That Met QC Criteria

February 3, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-010083-42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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