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

United Arab Emirates University

Status: Withdrawn

Conditions: Asthma

Treatments: Dietary Supplement: Placebo Drops; Dietary Supplement: Vitamin D3 (Cholecalciferol)

Study type: Interventional

Funder types: Other

Identifiers

NCT01284907

AAMDHREC NO: 09/58

Details and patient eligibility

About

The purpose of this study is to determine whether vitamin D supplements can improve asthma control in children with moderate to severe asthma

Full 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.

Sex: All

Ages: 6 to 12 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Vit D

Active Comparator group

Treatment:

Dietary Supplement: Vitamin D3 (Cholecalciferol)

Placebo drops

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo Drops