Official Title

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

    N/A
  • Study Type

    Interventional
  • Status

    Withdrawn
  • Study Participants

    0
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.
Study Started
Mar 31
2013
Primary Completion
Sep 30
2013
Anticipated
Study Completion
Dec 31
2013
Anticipated
Last Update
Dec 17
2014
Estimate

Dietary Supplement Vitamin D3 (Cholecalciferol)

Vit D3 ( Cholecalciferol) 1200 IU oral daily for 6 months

  • Other names: Cholecalciferol

Dietary Supplement Placebo Drops

Vit D Active Comparator

Placebo drops Placebo Comparator

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.
No Results Posted