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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01284907
Recruitment Status : Withdrawn (No Participants)
First Posted : January 27, 2011
Last Update Posted : December 17, 2014
Information provided by:

Study Description
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

Condition or disease Intervention/treatment
Asthma Dietary Supplement: Vitamin D3 (Cholecalciferol) 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Vit D to Treat Asthma in Children: a Randomized, Double-blind, Placebo-controlled Trial
Study Start Date : March 2013
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Vitamin D
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. A change from baseline in Peak expiratory flow rate [ Time Frame: up to six months ]

Secondary Outcome Measures :
  1. A change from baseline in lung function test [ Time Frame: up to six months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284907

United Arab Emirates
Tawam Hospital
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
Principal Investigator: Mariam Elremeli, MD Roma Paediatrics
More Information

Responsible Party: Dr Mariam Elremeli, Roma Paediatrics
ClinicalTrials.gov Identifier: NCT01284907     History of Changes
Other Study ID Numbers: AAMDHREC NO: 09/58
First Posted: January 27, 2011    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: December 2014

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

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