Vit D to Treat Asthma in Children: a Randomized, Double-blind, Placebo-controlled Trial
NCT ID: NCT01284907
Last Updated: 2014-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2013-03-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vit D
Vitamin D3 (Cholecalciferol)
Vit D3 ( Cholecalciferol) 1200 IU oral daily for 6 months
Placebo drops
Placebo Drops
Interventions
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Vitamin D3 (Cholecalciferol)
Vit D3 ( Cholecalciferol) 1200 IU oral daily for 6 months
Placebo Drops
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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.
6 Years
12 Years
ALL
No
Sponsors
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Roma Paediatrics
UNKNOWN
United Arab Emirates University
OTHER
Responsible Party
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Roma Paediatrics
Principal Investigators
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Mariam Elremeli, MD
Role: PRINCIPAL_INVESTIGATOR
Roma Paediatrics
Locations
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Tawam Hospital
Al Ain City, , United Arab Emirates
Al Ain Hospital
Al Ain City, , United Arab Emirates
Countries
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Other Identifiers
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AAMDHREC NO: 09/58
Identifier Type: -
Identifier Source: org_study_id