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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by United Arab Emirates University.
Recruitment status was  Not yet recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 22, 2014