Asthma
Conditions
Keywords
Asthma, Asthma therapy, Randomized controlled trial, children
Brief summary
The purpose of this study is to determine whether vitamin D supplements can improve asthma control in children with moderate to severe asthma
Detailed description
The proposed interventional study will clarify the role of vitamin D in preventing asthma exacerbations and in achieving better chronic asthma control in children with moderate to severe asthma.
Interventions
DIETARY_SUPPLEMENTVitamin D3 (Cholecalciferol)
Vit D3 ( Cholecalciferol) 1200 IU oral daily for 6 months
DIETARY_SUPPLEMENTPlacebo Drops
Sponsors
Roma Paediatrics
United Arab Emirates University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Physician diagnosed asthmatics and they should fulfill at least two of the following three criteria: * A minimum of three clinic visits for acute asthma within 1 year * Two or more asthma-related hospital admissions within 1 year, or * Steroid dependency, as defined by either 6 months of oral or 1 year of inhaled corticosteroid use * Age: 6-14 years old. The age group of 6 to 14 years old was chosen for two reasons: 1. Diagnostic accuracy of asthma is better in this age group as non-specific wheezers less than 6 years of age could be excluded. 2. Child should be able to use a peak flow meter and perform spirometry tests. * A positive specific IgE or a positive skin prick test for at least one airborne allergen.
Exclusion criteria
* Children with mild intermittent and mild persistent asthma. * Asthmatic children who are currently on immunotherapy or anti IgE. * Asthmatic children with concomitant other medical problems. * Children who are younger than 6 yrs or older than 14 yrs. * Children with history of early life injury to airways like premature birth (\< 36 weeks) or home use of oxygen. * Children with vitamin D deficiency. Since these children may be randomized to the control group, they will be excluded for ethical reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A change from baseline in Peak expiratory flow rate | up to six months |
Secondary
| Measure | Time frame |
|---|---|
| A change from baseline in lung function test | up to six months |
Countries
United Arab Emirates
Outcome results
None listed