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OpenTrials
Completed

NCT Number: NCT00978315

Trial of Vitamin D Supplementation in 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.

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Key information

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Barts and The London NHS Trust, London, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Dietary Supplement

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

Miglyol oil

Dietary Supplement

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

Primary outcomes

  1. Time to first upper respiratory tract infection

    Time frame: One year

  2. Time to first severe asthma exacerbation

    Time frame: One year

Secondary outcomes

  1. Asthma Control Test Score

    Time frame: One year

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

    Time frame: One year

  3. Proportion of participants experiencing hypercalcaemia

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Collaborators

  • National Health Service, United Kingdom

Registry information

Official study title

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

Acronym: ViDiAs

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Sep 16, 2009
Registry last updated
Feb 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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