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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01284907
• Other study ID #: AAMDHREC NO: 09/58
• Status: Withdrawn
• Phase: N/A
• First received: January 24, 2011
• Last updated: December 16, 2014
• Start date: March 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: United Arab Emirates University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Arab Emirates: General Authority for Health Services for Abu Dhabi
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Dietary Supplement:
• Vitamin D3 (Cholecalciferol)
Vit D3 ( Cholecalciferol) 1200 IU oral daily for 6 months
• Placebo Drops

Locations

Country	Name	City	State
United Arab Emirates	Al Ain Hospital	Al Ain
United Arab Emirates	Tawam Hospital	Al Ain

Sponsors (2)

Lead Sponsor	Collaborator
United Arab Emirates University	Roma Paediatrics

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A change from baseline in Peak expiratory flow rate		up to six months	No
Secondary	A change from baseline in lung function test		up to six months	No