Status:
UNKNOWN
Orthomolecular Therapy and Asthma in Children
Lead Sponsor:
Canadian Institute of Natural and Integrative Medicine
Collaborating Sponsors:
Alberta Children's Hospital
Alberta Health services
Conditions:
Asthma
Eligibility:
All Genders
7-18 years
Phase:
PHASE2
Brief Summary
The purpose of this study is 1. To pilot the research methodology for a randomized trial on an orthomolecular treatment regime versus placebo as add-on therapy for children with asthma; 2. To obtain ...
Detailed Description
An orthomolecular treatment approach that combines supplements has, to date, not been tested, although it is commonly used by naturopathic practitioners to treat respiratory problems in individual chi...
Eligibility Criteria
Inclusion
- Male or female aged 7 to 18 years
- Mild to moderate asthma diagnosed by a respirologist
- Use of budesonide at a dose of 200-800 µg/d (or equivalent corticosteroid therapy) for ≥3 months
- Stable asthma, defined as no significant change in the regular asthma medication and no acute asthma exacerbation requiring corticosteroid rescue for at least 3 months before enrollment in the run-in phase. Asthma symptoms must be under good control
- Baseline forced expiratory volume at 1 second (FEV-1) \>= 70% of the predicted normal value.
- Possible participants treated with orthomolecular therapies within the previous year will require a wash out period of 7 days prior to enrolment in the trial. (Vitamin C \> 200mg, Vitamin E \>50IU, Vitamin B12 \> 100µg, Magnesium \> 200mg, Selenium \> 50µg, Omega-3 \> 300mg, Quercetin \> 3mg, Vitamin B6 \> 75mg will all be considered orthomolecular doses).
Exclusion
- Known hypersensitivity to any component of the orthomolecular therapy or placebo.
- Acute infectious sinusitis or respiratory tract infection or active lung disease other than allergic asthma within 1 month or any other significant systemic disease within 3 months of the study entry visit.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2013
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00672529
Start Date
February 1 2011
End Date
March 1 2013
Last Update
February 4 2011
Active Locations (1)
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1
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8