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

This study has been withdrawn prior to enrollment.
(No Participants)
Sponsor:
Collaborator:
Roma Paediatrics
Information provided by:
United Arab Emirates University
ClinicalTrials.gov Identifier:
NCT01284907
First received: January 24, 2011
Last updated: December 16, 2014
Last verified: December 2014

January 24, 2011
December 16, 2014
March 2013
September 2013   (final data collection date for primary outcome measure)
A change from baseline in Peak expiratory flow rate [ Time Frame: up to six months ] [ Designated as safety issue: No ]
A change from baseline in Peak expiratory flow rate [ Time Frame: Daily for six months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01284907 on ClinicalTrials.gov Archive Site
A change from baseline in lung function test [ Time Frame: up to six months ] [ Designated as safety issue: No ]
A change from baseline in lung function test [ Time Frame: Monthly for six months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Vit D to Treat Asthma in Children: a Randomized, Double-blind, Placebo-controlled Trial
Vit D to Treat Asthma in Children: a Randomized, Double-blind, Placebo-controlled Trial
The purpose of this study is to determine whether vitamin D supplements can improve asthma control in children with moderate to severe asthma
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Asthma
  • Dietary Supplement: Vitamin D3 (Cholecalciferol)
    Vit D3 ( Cholecalciferol) 1200 IU oral daily for 6 months
    Other Name: Cholecalciferol
  • Dietary Supplement: Placebo Drops
  • Active Comparator: Vit D
    Intervention: Dietary Supplement: Vitamin D3 (Cholecalciferol)
  • Placebo Comparator: Placebo drops
    Intervention: Dietary Supplement: Placebo Drops
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2013
September 2013   (final data collection date for primary outcome measure)

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.
Both
6 Years to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United Arab Emirates
 
NCT01284907
AAMDHREC NO: 09/58
Yes
Not Provided
Not Provided
Dr Mariam Elremeli, Roma Paediatrics
United Arab Emirates University
Roma Paediatrics
Principal Investigator: Mariam Elremeli, MD Roma Paediatrics
United Arab Emirates University
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP