NCT00978315

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_2 asthma

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_2 asthma

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

February 4, 2014

Status Verified

February 1, 2014

Enrollment Period

3.8 years

First QC Date

September 14, 2009

Last Update Submit

February 3, 2014

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

  • Time to first upper respiratory tract infection

    One year

  • Time to first severe asthma exacerbation

    One year

Secondary Outcomes (3)

  • 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

Study Arms (2)

Vigantol oil

ACTIVE COMPARATOR

Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year

Dietary Supplement: Cholecalciferol

Miglyol oil

PLACEBO COMPARATOR

Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year

Dietary Supplement: Miglyol oil

Interventions

CholecalciferolDIETARY_SUPPLEMENT

Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year

Vigantol oil
Miglyol oilDIETARY_SUPPLEMENT

Miglyol oil will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year

Miglyol oil

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Barts and The London NHS Trust

London, London, E1 1BB, United Kingdom

Location

Lower Clapton Health Centre

London, London, E5 0PD, United Kingdom

Location

Homerton University Hospital NHS Foundation Trust

London, London, E9 6SR, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, London, SE1 9RT, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 25724847DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Adrian R Martineau, MRCP

    Queen Mary University of London

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2009

First Posted

September 16, 2009

Study Start

September 1, 2009

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

February 4, 2014

Record last verified: 2014-02

Locations

GB(4)