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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