Orthomolecular Therapy and Asthma in Children
Orthomolecular Therapy and Asthma in Children
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 a preliminary estimate of the effectiveness of an orthomolecular treatment
 regime for allowing tapering of inhaled corticosteroids in clinically stable asthmatic
 children. The obtained estimate will allow sample size calculations for a full-scale
 randomized trial; and

 3. To obtain preliminary information about the safety and tolerability of an orthomolecular
 treatment regime.
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 children. A well-designed controlled trial is needed to determine if this approach
 is effective. This smaller study should establish guidelines for a large trial to follow.
 This proposed research is particularly important, as the trend to use natural treatments may
 encourage non-compliance with conventional medical treatments, leading to poor asthma
 control.
Inclusion Criteria:

 -  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 Criteria:

 -  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.