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
  Purpose

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


Condition Intervention
Asthma
Dietary Supplement: Vitamin D3 (Cholecalciferol)
Dietary Supplement: Placebo Drops

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Vit D to Treat Asthma in Children: a Randomized, Double-blind, Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by United Arab Emirates University:

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

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

Estimated Enrollment: 200
Study Start Date: March 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vit D Dietary Supplement: Vitamin D3 (Cholecalciferol)
Vit D3 ( Cholecalciferol) 1200 IU oral daily for 6 months
Other Name: Cholecalciferol
Placebo Comparator: Placebo drops Dietary Supplement: Placebo Drops

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284907

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

Locations
United Arab Emirates
Tawam Hospital Not yet recruiting
Al Ain, United Arab Emirates, P. O. Box: 15258
Al Ain Hospital
Al Ain, United Arab Emirates, P.O.Box: 1006
Sponsors and Collaborators
United Arab Emirates University
Roma Paediatrics
Investigators
Principal Investigator: Mariam Elremeli, MD Roma Paediatrics
  More Information

No publications provided

Responsible Party: Dr Mariam Elremeli, Roma Paediatrics
ClinicalTrials.gov Identifier: NCT01284907     History of Changes
Other Study ID Numbers: AAMDHREC NO: 09/58
Study First Received: January 24, 2011
Last Updated: September 21, 2012
Health Authority: United Arab Emirates: General Authority for Health Services for Abu Dhabi

Keywords provided by United Arab Emirates University:
Asthma
Asthma therapy
Randomized controlled trial
children

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cholecalciferol
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 15, 2014