Orthomolecular Therapy and Asthma in Children

Study Overview
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Brief Summary
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The purpose of this study is To pilot the research methodology for a randomized trial on an orthomolecular treatment regime versus placebo as add-on therapy for children with asthma; 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 To obtain preliminary information about the safety and tolerability of an orthomolecular treatment regime.

Detailed Description
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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.

Official Title
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Orthomolecular Treatment as add-on Therapy for Childhood Asthma

Conditions
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Asthma

Intervention / Treatment
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* Dietary Supplement: Orthomolecular Therapy or Placebo Comparator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group<br> | Dietary Supplement: Orthomolecular Therapy or Placebo Comparator<br>* The custom formulation proposed in this study comprises Vitamins C, E, B6 and B12, magnesium, selenium, quercetin and fish oil in relatively large doses. It is not at present registered as a natural health product or drug product. Eligible patients will be randomized to an orthomolecular treatment regime or placebo with a 2:1 randomization ratio and will remain on their randomized treatment for 16 weeks. For the first 8 weeks of the intervention period inhaled corticosteroid treatment will be unchanged. In the remaining 8 weeks dose adjustment will occur every two weeks. Participants will be monitored closely for changes in their lung function.<br>* Other names: CIN-AST-01;|
| Placebo Comparator: Placebo Group<br> | Dietary Supplement: Orthomolecular Therapy or Placebo Comparator<br>* The custom formulation proposed in this study comprises Vitamins C, E, B6 and B12, magnesium, selenium, quercetin and fish oil in relatively large doses. It is not at present registered as a natural health product or drug product. Eligible patients will be randomized to an orthomolecular treatment regime or placebo with a 2:1 randomization ratio and will remain on their randomized treatment for 16 weeks. For the first 8 weeks of the intervention period inhaled corticosteroid treatment will be unchanged. In the remaining 8 weeks dose adjustment will occur every two weeks. Participants will be monitored closely for changes in their lung function.<br>* Other names: CIN-AST-01;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The last tolerated dose of inhaled corticosteroids will be the primary end point. |  | To safeguard against the possibility of excessive adverse events related to the tapering procedures or the orthomolecular treatment, an interim analysis will be conducted after 50% accrual is reached in this pilot investigation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number (percentage) of patients with failed tapering and failed rescue will serve as secondary endpoint. |  | See primary endpoint | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Childhood Asthma, Inhaled Corticosteroids, Alternative Medicine, Vitamins, minerals, and fish oil as Add-on Treatment