Vit D to Treat Asthma in Children: a Randomized, Double-blind, Placebo-controlled Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vit D to Treat Asthma in Children: a Randomized, Double-blind, Placebo-controlled Trial

Conditions
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Asthma

Intervention / Treatment
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* Dietary Supplement: Vitamin D3 (Cholecalciferol)
* Dietary Supplement: Placebo Drops


Participation Criteria
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Eligibility Criteria
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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: Diagnostic accuracy of asthma is better in this age group as non-specific wheezers less than 6 years of age could be excluded. 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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vit D<br> | Dietary Supplement: Vitamin D3 (Cholecalciferol)<br>* Vit D3 ( Cholecalciferol) 1200 IU oral daily for 6 months<br>* Other names: Cholecalciferol;|
| Placebo Comparator: Placebo drops<br> | Dietary Supplement: Placebo Drops<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change from baseline in Peak expiratory flow rate |  | up to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change from baseline in lung function test |  | up to six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Asthma therapy, Randomized controlled trial, children