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DIVA study

Help us to improve care of children with asthma

Many preschool-aged children with asthma experience flare-ups that are triggered by colds, particularly during winter.

Despite the use of asthma medications, many  flare-ups get worse and require a visit to the emergency room, or even hospital admission. While there are good medications to control asthma, there is no way to prevent colds in children aside from trying to reduce the spread of germs.

Research studies are exploring whether large doses of vitamin D supplements could reduce the severity of asthma flare-ups, triggered by colds, in preschool-aged children.

This study seeks young children who have been diagnosed with asthma. Participants are required to attend 3 study visits at the research site over a 7 month period and will be compensated  for their parking cost at each research visit.

The study in details...


Why Participate?

  • Your child may experience an improvement in their asthma symptoms, simply by participating in this study that will be providing regular medical and nursing care.
  • Your child may receive a Vitamin D supplement that is not currently available on the market and that the investigators believe could be beneficial for lung health, and immune system.
  • Your child will be closely monitored by an Asthma specialist
  • You may be helping in discovering a potential alternative to improve asthma management.
  • Your travel and parking costs will be reimbursed for each research visit.
  • Your child will be helping to advance medical research aimed at improving the health of young kids with asthma.


Eligibility criteria

The Department of Pediatrics is currently recruiting young children for a large study testing whether vitamin D supplements can reduce the severity of asthma flare-ups triggered by colds.

Is...

  • Is your child aged 1 to 5 years of age?
  • Has your child been diagnosed with asthma or bronchospasm?
  • Has your child received steroid by month (solution or syrup) for asthma during his current hospital visit or in the last 12 months?
  • Has the child had ≥ 4 colds in the past 12 months?
  • Do the asthma flare-ups appear to be mainly triggered by colds?

If your child fits all 5 criteria, he/she may be eligible to be part of a large Canadian study testing the effect of vitamin D in preschoolers with asthma.

This study will enroll children annually from 2018 to 2024.

 


Study Layout

Goal

  • Evaluate if vitamin D supplementation can reduce the severity of asthma attacks in children between 1 and 5 years old.

Duration

  • 7 months

Progress

Clinic VISIT 1 (Day0)

Duration**: about 90-150 minutes

  • Nasal swab collection
  • Urine and blood samples collection
  • Oral administration (by mouth) of a 2 mL dose of liquid Vitamin D or placebo
  • Questionnaires on food intake and sun exposure
  • Questionnaire on colds and asthma attacks
  • Measurement of lung function with oscillometry test, if applicable

Clinic VISIT 2* (3 ½ months)

Duration**: about 90-150 minutes

  • Nasal swab collection
  • Urine samples collection
  • Oral administration (by mouth) of a 2 mL dose of liquid Vitamin D or placebo
  • Questionnaire sur l’absentéisme au travail et dépenses reliées aux crises d’asthme de votre enfant
  • Questionnaires on food intake and sun exposure
  • Questionnaire on colds and asthma attacks
  • Measurement of lung function with oscillometry test, if applicable

Clinic VISIT 3* (7 months)

Duration**: about 90 minutes

  • Urine and blood samples collection
  • Questionnaire sur l’absentéisme au travail et dépenses reliées aux crises d’asthme de votre enfant
  • Questionnaires on food intake and sun exposure
  • Questionnaire on colds and asthma attacks
  • Measurement of lung function with oscillometry test, if applicable

*  Or Remote visit by videoconferencing, if applicable
** Excluding the medical visit duration

Between hospital visits

DAILY administration of 1 mL of vitamin D or placebo by parents

Urine sample collection at home (10 days after Visit 1 and after Visit 2)
If the urine test is abnormal:  Home visit for blood sample by medical technologist/nurse or by parents with a special kit. Of note, a 2nd urine collection might be repeated first.

Telephone follow-ups by the research nurse

  • 7 days after Visits 1 and 2
  • Once a month between visits

In case of asthma attack or cold (at home)

  • Perform the nasal swab sample on day 2 (or 3 or 4) of each episode
  • Fill out the questionnaires (online or on paper)
    • Symptoms diary every day throughout the episode
    • Quality-of-life questionnaire for the parent at the end of the episode
    • Summary of cold or asthma flare-up at the end of the episode


Flowchart


Study procedures? (videos)

How to complete the questionnaires

Instructions on questionnaires to be completed during a child's cold and asthma flare-up.


How to collect a nasal sample


How to collect a urine sample


How to collect a capillary blood sample at home

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About this page
Updated on 4/24/2024
Created on 8/18/2023
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