Vit D to Treat Asthma in Children: a Randomized, Double-blind, Placebo-controlled Trial
Overview
The purpose of this study is to determine whether vitamin D supplements can improve asthma control in children with moderate to severe asthma
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Care Provider, Investigator)
- Study Primary Completion Date: September 2013
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 Supplement: Vitamin D3 (Cholecalciferol)
- Vit D3 ( Cholecalciferol) 1200 IU oral daily for 6 months
- Dietary Supplement: Placebo Drops
Arms, Groups and Cohorts
- Active Comparator: Vit D
- Placebo Comparator: Placebo drops
Clinical Trial Outcome Measures
Primary Measures
- A change from baseline in Peak expiratory flow rate
- Time Frame: up to six months
Secondary Measures
- A change from baseline in lung function test
- Time Frame: up to six months
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 6 Years
Maximum Age: 12 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- United Arab Emirates University
- Collaborator
- Roma Paediatrics
- Provider of Information About this Clinical Study
- Dr Mariam Elremeli, Roma Paediatrics
- Overall Official(s)
- Mariam Elremeli, MD, Principal Investigator, Roma Paediatrics
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