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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 24, 2011

Last Updated Date

September 21, 2012

Start Date ^ICMJE

March 2013

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

A change from baseline in Peak expiratory flow rate [ Time Frame: up to six months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

A change from baseline in Peak expiratory flow rate [ Time Frame: Daily for six months ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01284907 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

A change from baseline in lung function test [ Time Frame: up to six months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

A change from baseline in lung function test [ Time Frame: Monthly for six months ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Asthma

Intervention ^ICMJE

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

Other Name: Cholecalciferol
Dietary Supplement: Placebo Drops

Study Arm (s)

Active Comparator: Vit D
Intervention: Dietary Supplement: Vitamin D3 (Cholecalciferol)
Placebo Comparator: Placebo drops
Intervention: Dietary Supplement: Placebo Drops

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2013

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

6 Years to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Mariam Elremeli, MD	+971 50 7430721	mremeli@gmail.com
Contact: Raihan El Naas, MD	+971507430721	romaclinic@hotmail.com

Location Countries ^ICMJE

United Arab Emirates

Administrative Information

NCT Number ^ICMJE

NCT01284907

Other Study ID Numbers ^ICMJE

AAMDHREC NO: 09/58

Has Data Monitoring Committee

Yes

Responsible Party

Dr Mariam Elremeli, Roma Paediatrics

Study Sponsor ^ICMJE

United Arab Emirates University

Collaborators ^ICMJE

Roma Paediatrics

Investigators ^ICMJE

Principal Investigator:

Mariam Elremeli, MD

Roma Paediatrics

Information Provided By

United Arab Emirates University

Verification Date

September 2012

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

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