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:
United Arab Emirates University
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
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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:
- Diagnostic accuracy of asthma is better in this age group as non-specific wheezers less than 6 years of age could be excluded.
- 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 May 21, 2013