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

Primary Purpose

Asthma

Status
Withdrawn
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Vitamin D3 (Cholecalciferol)
Placebo Drops
Sponsored by
United Arab Emirates University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Asthma therapy, Randomized controlled trial, children

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tawam Hospital
  • Al Ain Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vit D

Placebo drops

Arm Description

Outcomes

Primary Outcome Measures

A change from baseline in Peak expiratory flow rate

Secondary Outcome Measures

A change from baseline in lung function test

Full Information

First Posted
January 24, 2011
Last Updated
December 16, 2014
Sponsor
United Arab Emirates University
Collaborators
Roma Paediatrics
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1. Study Identification

Unique Protocol Identification Number
NCT01284907
Brief Title
Vit D to Treat Asthma in Children: a Randomized, Double-blind, Placebo-controlled Trial
Official Title
Vit D to Treat Asthma in Children: a Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Withdrawn
Why Stopped
No Participants
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
United Arab Emirates University
Collaborators
Roma Paediatrics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Asthma therapy, Randomized controlled trial, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vit D
Arm Type
Active Comparator
Arm Title
Placebo drops
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3 (Cholecalciferol)
Other Intervention Name(s)
Cholecalciferol
Intervention Description
Vit D3 ( Cholecalciferol) 1200 IU oral daily for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Drops
Primary Outcome Measure Information:
Title
A change from baseline in Peak expiratory flow rate
Time Frame
up to six months
Secondary Outcome Measure Information:
Title
A change from baseline in lung function test
Time Frame
up to six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariam Elremeli, MD
Organizational Affiliation
Roma Paediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tawam Hospital
City
Al Ain
ZIP/Postal Code
P. O. Box: 15258
Country
United Arab Emirates
Facility Name
Al Ain Hospital
City
Al Ain
ZIP/Postal Code
P.O.Box: 1006
Country
United Arab Emirates

12. IPD Sharing Statement

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

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