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

December 16, 2014 updated by: United Arab Emirates University
The purpose of this study is to determine whether vitamin D supplements can improve asthma control in children with moderate to severe asthma

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Arab Emirates
      • Al Ain, United Arab Emirates, P. O. Box: 15258
        • Tawam Hospital
      • Al Ain, United Arab Emirates, P.O.Box: 1006
        • Al Ain Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo drops
Dietary supplement: Placebo Drops
Active Comparator: Vit D
Dietary supplement: Vitamin D3 (Cholecalciferol)
Vit D3 ( Cholecalciferol) 1200 IU oral daily for 6 months
Other Names:
  • Cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A change from baseline in Peak expiratory flow rate
Time Frame: up to six months
up to six months

Secondary Outcome Measures

Outcome Measure
Time Frame
A change from baseline in lung function test
Time Frame: up to six months
up to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United Arab Emirates University

Collaborators

Roma Paediatrics

Investigators

  • Principal Investigator: Mariam Elremeli, MD, Roma Paediatrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

January 24, 2011

First Submitted That Met QC Criteria

January 26, 2011

First Posted (Estimate)

January 27, 2011

Study Record Updates

Last Update Posted (Estimate)

December 17, 2014

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAMDHREC NO: 09/58

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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