Trial of Vitamin D Supplementation in Asthma (ViDiAs)

This study has been completed.
Sponsor:
Collaborator:
National Health Service, United Kingdom
Information provided by (Responsible Party):
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT00978315
First received: September 14, 2009
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Dietary Supplement: Cholecalciferol
Dietary Supplement: Miglyol oil
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomised, Multi-centre, Double-blind, Placebo-controlled Trial of Vitamin D Supplementation in Adult and Adolescent Patients With Asthma

Resource links provided by NLM:


Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • Time to first upper respiratory tract infection [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Time to first severe asthma exacerbation [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Asthma Control Test Score [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Time to unscheduled health service use for upper respiratory tract infection or severe asthma exacerbation [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Proportion of participants experiencing hypercalcaemia [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Enrollment: 250
Study Start Date: September 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978315

Locations
United Kingdom
Barts and The London NHS Trust
London, United Kingdom, E1 1BB
Homerton University Hospital NHS Foundation Trust
London, United Kingdom, E9 6SR
Lower Clapton Health Centre
London, United Kingdom, E5 0PD
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Barts & The London NHS Trust
National Health Service, United Kingdom
Investigators
Study Director: Adrian R Martineau, MRCP Queen Mary University of London
  More Information

No publications provided

Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT00978315     History of Changes
Other Study ID Numbers: 2009-010083-42
Study First Received: September 14, 2009
Last Updated: February 3, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cholecalciferol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014