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

This study is not yet open for participant recruitment.
Verified September 2012 by United Arab Emirates University
Sponsor:
Collaborator:
Roma Paediatrics
Information provided by:
United Arab Emirates University
ClinicalTrials.gov Identifier:
NCT01284907
First received: January 24, 2011
Last updated: September 21, 2012
Last verified: September 2012

January 24, 2011
September 21, 2012
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.
 
Not yet recruiting
200
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
No
Contact: Mariam Elremeli, MD +971 50 7430721 mremeli@gmail.com
Contact: Raihan El Naas, MD +971507430721 romaclinic@hotmail.com
United Arab Emirates
 
NCT01284907
AAMDHREC NO: 09/58
Yes
Dr Mariam Elremeli, Roma Paediatrics
United Arab Emirates University
Roma Paediatrics
Principal Investigator: Mariam Elremeli, MD Roma Paediatrics
United Arab Emirates University
September 2012

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