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

Not Applicable

Withdrawn

• Conditions: Asthma
• Interventions: Dietary Supplement: Placebo Drops; Dietary Supplement: Vitamin D3 (Cholecalciferol)

• Registration Number: NCT01284907
• Lead Sponsor: United Arab Emirates University

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.

Study Timeline

• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Study Start: 2013-03
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo drops	Placebo Drops	-
Vit D	Vitamin D3 (Cholecalciferol)	-

Primary Outcome Measures

Name	Time	Method
A change from baseline in Peak expiratory flow rate	up to six months

Secondary Outcome Measures

Name	Time	Method
A change from baseline in lung function test	up to six months

Trial Locations

Locations (2)

Tawam Hospital; 🇦🇪 Al Ain, United Arab Emirates

Al Ain Hospital; 🇦🇪 Al Ain, United Arab Emirates